Category: Drugs Advisories

FDA Advisory No. 2019-388 || Incorrect Use of Anti-Fungal Corticosteroid Combination Therapy

Nowadays, internet and social media has influenced the lives of Filipinos. Physical appearance on Facebook and Instagram posts is a great concern, it is now expected to look best all the time. And when a skin problem arises, solutions and treatment are searched through the internet instead of consulting a dermatologist to address skin problems. Unfortunately, the use of products widely available and sold in the internet and unlicensed establishments make the skin problems worse one such product is LS BL Cream containing Ketoconazole and Clobetasol and is well-known to the public to cure all types of skin problems.

Pharmacists are advised not to dispense the product without a written prescription from dermatologists or treating physician. Upon presentation of prescription, patients should undergo counselling on the proper use of the product to avoid serious health risks and worsening of their conditions.

The general public is also advised to avoid using the product without proper consultation from dermatologist. It is a prescription product used for the treatment of fungal and yeasts infections. The product contains a very potent steroid which may result in side effects such as worsening condition, acne, skin infections, skin thinning, changes to the color of skin, allergic reaction, increased weight, rounding of the face, stretch marks, etc. There is a recorded case who experienced side effect on the use of Ketoconazole + Clobetasol cream which eventually resulted to death due to staphylococcal scalded skin syndrome associated with the use of topical steroid.

We strongly urge the public to buy medicines only from an FDA licensed drugstores and avoid buying medicines online.

Also, please be informed that there is a proliferation of Ketoconazole + Clobetasol Propionate (LS BL Cream) 10 g in the market which is not registered to the Food and Drug Administration (FDA). The drug product has not gone through the registration and testing process and has not been issued with proper authorization in the form of Certificate of Product Registration. Thus, we cannot guarantee their quality and safety.

Seek medical attention immediately if you experience any side effects and report it to FDA via online reporting through our website: www.fda.gov.ph or email at [email protected]. You may also reach us at telephone number (02) 8809-5596.

Attachment:-> FDA Advisory No. 2019-388

FDA Advisory No. 2019-472-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Ravi Mangosteen Power Liniment with Negative Ion 60mL

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng hindi rehistradong gamot na:

  1. Ravi Mangosteen Power Liniment with Negative Ion 60mL

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon o pag-eeksamin ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Samakatuwid, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Ang nasabing iligal na produkto ay maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang publiko ay pinapaalalahanang huwag bumili ng nasabing iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facilityeReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: www.fda.gov.ph/adr-report-new at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:-> FDA ADVISORY No. 2019-472-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-472-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Ravi Mangosteen Power Liniment with Negative Ion 60mL

FDA Advisory No. 2019-472 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Ravi Mangosteen Power Liniment with Negative Ion 60mL

The Food and Drug Administration (FDA) advises the public against the purchase and use of the unregistered drug product:

  1. Ravi Mangosteen Power Liniment with Negative Ion 60mL

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug product has not gone through the registration and testing process of the Agency and has not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. The consumption of such violative product may pose potential danger or injury if administered.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug product until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02)809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA ADVISORY No. 2019-472

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-472 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Ravi Mangosteen Power Liniment with Negative Ion 60mL

FDA Advisory No. 2019-471-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Menthol + Eucalyptus Oil (Ugat Bicks)

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng hindi rehistradong gamot na:

  1. Menthol + Eucalyptus Oil (Ugat Bicks)

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon o pag-eeksamin ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Samakatuwid, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Ang nasabing iligal na produkto ay maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang publiko ay pinapaalalahanang huwag bumili ng nasabing iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facilityeReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: www.fda.gov.ph/adr-report-new at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:-> FDA ADVISORY No. 2019-471-A

FDA Advisory No. 2019-471 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Menthol + Eucalyptus Oil (Ugat Bicks)

The Food and Drug Administration (FDA) advises the public against the purchase and use of the unregistered drug product:

  1. Menthol + Eucalyptus Oil (Ugat Bicks)

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug product has not gone through the registration and testing process of the Agency and has not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. The consumption of such violative product may pose potential danger or injury if administered.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug product until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02)809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA ADVISORY No. 2019-471

FDA Advisory No. 2019-470-A || Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng hindi rehistradong gamot na:

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng hindi rehistradong gamot na:

  1. Povidone-Iodine 10% Sol.

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon o pag-eeksamin ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Samakatuwid, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Ang nasabing iligal na produkto ay maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang publiko ay pinapaalalahanang huwag bumili ng nasabing iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facilityeReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: www.fda.gov.ph/adr-report-new at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:-> FDA ADVISORY No. 2019-470-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-470-A || Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng hindi rehistradong gamot na:

FDA Advisory No. 2019-470 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Povidone-Iodine 10% Sol.

The Food and Drug Administration (FDA) advises the public against the purchase and use of the unregistered drug product:

  1. Povidone-Iodine 10% Sol.

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug product has not gone through the registration and testing process of the Agency and has not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. The consumption of such violative product may pose potential danger or injury if administered.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug product until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02)809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA ADVISORY No. 2019-470

FDA Advisory No. 2019-469-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Family™ Care Quickly Relieves Itching & Redness Maximum Strength Hydrocortisone 1% Anti-Itch Cream

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng hindi rehistradong gamot na:

  1. Family™ Care Quickly Relieves Itching & Redness Maximum Strength Hydrocortisone 1% Anti-Itch Cream

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon o pag-eeksamin ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Samakatuwid, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Ang nasabing iligal na produkto ay maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang publiko ay pinapaalalahanang huwag bumili ng nasabing iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facilityeReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: www.fda.gov.ph/adr-report-new at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:-> FDA ADVISORY No. 2019-469-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-469-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Family™ Care Quickly Relieves Itching & Redness Maximum Strength Hydrocortisone 1% Anti-Itch Cream

FDA Advisory No. 2019-469 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Family™ Care Quickly Relieves Itching & Redness Maximum Strength Hydrocortisone 1% Anti-Itch Cream

The Food and Drug Administration (FDA) advises the public against the purchase and use of the unregistered drug product:

  1. Family™ Care Quickly Relieves Itching & Redness Maximum Strength Hydrocortisone 1% Anti-Itch Cream

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug product has not gone through the registration and testing process of the Agency and has not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. The consumption of such violative product may pose potential danger or injury if administered.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug product until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02)809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA ADVISORY No. 2019-469

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-469 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Family™ Care Quickly Relieves Itching & Redness Maximum Strength Hydrocortisone 1% Anti-Itch Cream

FDA Advisory No. 2019-468-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na OTC Compound Ketoconazole Cream

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng hindi rehistradong gamot na:

  1. OTC Compound Ketoconazole Cream

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon o pag-eeksamin ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Samakatuwid, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Ang nasabing iligal na produkto ay maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang publiko ay pinapaalalahanang huwag bumili ng nasabing iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facilityeReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: www.fda.gov.ph/adr-report-new at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:-> FDA ADVISORY No. 2019-468-A

FDA Advisory No. 2019-468 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product OTC Compound Ketoconazole Cream

The Food and Drug Administration (FDA) advises the public against the purchase and use of the unregistered drug product:

  1. OTC Compound Ketoconazole Cream

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug product has not gone through the registration and testing process of the Agency and has not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. The consumption of such violative product may pose potential danger or injury if administered.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug product until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02)809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA ADVISORY No. 2019-468

FDA Advisory No. 2019-467-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Trabongko Liniment (Oil Base) with Ginger Extract 60mL

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng hindi rehistradong gamot na:

  1. Trabongko Liniment (Oil Base) with Ginger Extract 60mL

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon o pag-eeksamin ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Samakatuwid, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Ang nasabing iligal na produkto ay maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang publiko ay pinapaalalahanang huwag bumili ng nasabing iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facilityeReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: www.fda.gov.ph/adr-report-new at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon

Attachment:-> FDA ADVISORY No. 2019-467-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-467-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Trabongko Liniment (Oil Base) with Ginger Extract 60mL

FDA Advisory No. 2019-467 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Trabongko Liniment (Oil Base) with Ginger Extract 60mL

The Food and Drug Administration (FDA) advises the public against the purchase and use of the unregistered drug product:

  1. Trabongko Liniment (Oil Base) with Ginger Extract 60mL

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug product has not gone through the registration and testing process of the Agency and has not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. The consumption of such violative product may pose potential danger or injury if administered.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug product until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02)809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:->FDA ADVISORY No. 2019-467

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-467 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Trabongko Liniment (Oil Base) with Ginger Extract 60mL

FDA Advisory No. 2019-466-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Extra Hot Balsem Gosok Cap Balsem Merah Betet Parrot Brand Balm Red Balm 17.5g

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng hindi rehistradong gamot na:

  1. Extra Hot Balsem Gosok Cap Balsem Merah Betet Parrot Brand Balm Red Balm 17.5g

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon o pag-eeksamin ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Samakatuwid, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Ang nasabing iligal na produkto ay maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang publiko ay pinapaalalahanang huwag bumili ng nasabing iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facilityeReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: www.fda.gov.ph/adr-report-new at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:-> FDA ADVISORY No. 2019-466-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-466-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Extra Hot Balsem Gosok Cap Balsem Merah Betet Parrot Brand Balm Red Balm 17.5g

FDA Advisory No. 2019-466 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Extra Hot Balsem Gosok Cap Balsem Merah Betet Parrot Brand Balm Red Balm 17.5g

The Food and Drug Administration (FDA) advises the public against the purchase and use of the unregistered drug product:

  1. Extra Hot Balsem Gosok Cap Balsem Merah Betet Parrot Brand Balm Red Balm 17.5g

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug product has not gone through the registration and testing process of the Agency and has not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. The consumption of such violative product may pose potential danger or injury if administered.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug product until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02)809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA ADVISORY No. 2019-466

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-466 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Extra Hot Balsem Gosok Cap Balsem Merah Betet Parrot Brand Balm Red Balm 17.5g

FDA Advisory No. 2019-395-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga hindi rehistradong gamot na:

  1. AM YA FENG QUIKE COMPOUND
    PARACETAMOL AND AMANTADINE
    HYDROCHLORIDE CAPSULES
  2. RYUKAKUSAN DIRECT
  3. CORIX BURNSGEL
  4.  OTC SOUTH OCEAN RIDACHE® SHEXIANG
    QUTONG QIWUJI
  5.  GMP ROSMARINUS SCHNEISKI
  6. MUHI
  7. TON PHOR SCAR OIL CROCCO
  8. MUHI MOPIDICKS®-S
  9. NEW SMELL LESS AMMELTZ® YOKOYOKO
  10. 180 [Label in Foreign Language]
  11. RYUKAKU-SAN FOR PHLEGM, COUGH,
    HUSKINESS
  12. PEPPERMINT CURE ORIGINAL RICQLES
    [as reflected in the secondary packaging]
    ALCOOL DE MINTHE DE RICQLES [as reflected in
    the primary packaging]

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang nasabing mga gamot ay hindi dumaan sa proseso ng rehistrasyon o pageeksamin ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Samakatuwid, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Ang nasabing mga iligal na produkto ay maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang publiko ay pinapaalalahanang huwag bumili ng nasabing mga iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing mga iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang mga produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected] Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga Hindi rehistradong gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facility, eReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 809- 5596. Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: www.fda.gov.ph/adr-report-new at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Please see attachment for the photos:-> FDA Advisory No. 2019-395-A

FDA Advisory No. 2019-395 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:

  1. AM YA FENG QUIKE COMPOUND
    PARACETAMOL AND AMANTADINE
    HYDROCHLORIDE CAPSULES
  2. RYUKAKUSAN DIRECT
  3. CORIX BURNSGEL
  4.  OTC SOUTH OCEAN RIDACHE® SHEXIANG
    QUTONG QIWUJI
  5.  GMP ROSMARINUS SCHNEISKI
  6. MUHI
  7. TON PHOR SCAR OIL CROCCO
  8. MUHI MOPIDICKS®-S
  9. NEW SMELL LESS AMMELTZ® YOKOYOKO
  10. 180 [Label in Foreign Language]
  11. RYUKAKU-SAN FOR PHLEGM, COUGH,
    HUSKINESS
  12. PEPPERMINT CURE ORIGINAL RICQLES
    [as reflected in the secondary packaging]
    ALCOOL DE MINTHE DE RICQLES [as reflected in
    the primary packaging]

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration and testing process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential danger or injury if administered.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the aboveidentified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected] To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02)809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-reportnew and fill out all the required fields.

Dissemination of the information to all concerned is requested.

 Please see attachment for the photos:-> FDA Advisory No. 2019-395

FDA Advisory No. 2019-387-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga hindi rehistradong gamot na:

  1. OTC ORYZANOL TABLETS
  2. FEBUXOSTAT TABLETS
  3. AOLITAI ORNIDAZOLE CAPSULES
  4. Roxithromycin Capsules
  5. Omeprazole Sodium for INJECTION
  6. ADENOSINE DISODIUM TRIPHOSPHATE INJECTION
  7. JUCISHAN DEXAMETHASONE SODIUM PHOSPHATE INJECTION
  8. CEFTRIAXONE SODIUM FOR INJECTION
  9. ALLOPURINOL TABLETS
  10. CEFOTAXIME SODIUM FOR INJECTION
  11. ZX MOROXYDINE HYDROCHLORIDE TABLETS
  12. HUAN QIU FLUCONAZOLE AND SODIUM CHLORIDE INJECTION
  13. OTC FISHING PILL
  14. LUNDBECK FLUPENTIXOL AND MELITRACEN TABLETS (DEANXIT)
  15. ITRACONAZOLE HYDROCHLORIDE CAPSULES
  16. NEW LINDANE CREAM
  17. LUTEIN
  18. OTC PENTOXYVERINE CITRATE TABLETS
  19. OXYTETRACYCLINE TABLETS
  20. OTC FUFANGGANMAOLINGPIAN
  21. DIPYRIDAMOLE TABLETS
  22. OTC FUMASUAN TONGTIFEN PIAN
  23. OTC HOUKANG SAN
  24. OTC WEI C YINQIAO PIAN
  25. OTC [Label in Foreign Language]
  26. XCQM XUECHA QINGMU
  27. YABANG GROUP CARBAZOCHROME TABLETS
  28. ZN MENADIOL DIACETATE TABLETS
  29. BAOZHUPAI® [Label in Foreign Language]
  30. TRIVITAMINS B TABLETS [as reflected in the package insert]
  31. HUANQIU OFLOXACIN EAR DROPS [as reflected in the primary packaging and package insert]
  32. PR® RACEANISODAMINE TABLETS
  33. Jingkang Jiaonang
  34. 1 YI LHENG
  35. OTC [Label in Foreign Language]
  36. AZITHROMYCIN DISPERSIBLE TABLETS
  37. OTC NAPHAZOLINE HYDROCHLORIDE, CHLORPHENAMINE MALEATE AND VITAMIN B12 EYE DROPS EYE SIGHT
  38. KOUQIANGYAN PENWUJI
  39. OTC NYTH
  40. OTC ACUTE BRONCHITIS SYRUP
  41. OTC HUAHONG® XIAOZHONGZHITONGDING
  42. YUNNAN BAIYAO JIAONANG
  43. LOMEFLOXACIN HYDROCHLORIDE EYE DROPS
  44. OTC [Label in Foreign Language]
  45. OTC LORATADINE TABLETS [as reflected in the package insert]
  46. SPH DING LU BRAND® QINGGAN CHUANXINLIAN PIAN
  47. OTC 999® ZHENGTIAN WAN

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang nasabing mga gamot ay hindi dumaan sa proseso ng rehistrasyon o pag-eeksamin ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Samakatuwid, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Ang nasabing mga iligal na produkto ay maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang publiko ay pinapaalalahanang huwag bumili ng nasabing mga iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing mga iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang mga produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga Hindi rehistradong gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facilityeReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: www.fda.gov.ph/adr-report-new at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:->FDA Advisory No. 2019-387-A

FDA Advisory No. 2019-387 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:

  1. OTC ORYZANOL TABLETS
  2. FEBUXOSTAT TABLETS
  3. AOLITAI ORNIDAZOLE CAPSULES
  4. Roxithromycin Capsules
  5. Omeprazole Sodium for INJECTION
  6. ADENOSINE DISODIUM TRIPHOSPHATE INJECTION
  7. JUCISHAN DEXAMETHASONE SODIUM PHOSPHATE INJECTION
  8. CEFTRIAXONE SODIUM FOR INJECTION
  9. ALLOPURINOL TABLETS
  10. CEFOTAXIME SODIUM FOR INJECTION
  11. ZX MOROXYDINE HYDROCHLORIDE TABLETS
  12. HUAN QIU FLUCONAZOLE AND SODIUM CHLORIDE INJECTION
  13. OTC FISHING PILL
  14. LUNDBECK FLUPENTIXOL AND MELITRACEN TABLETS (DEANXIT)
  15. ITRACONAZOLE HYDROCHLORIDE CAPSULES
  16. NEW LINDANE CREAM
  17. LUTEIN
  18. OTC PENTOXYVERINE CITRATE TABLETS
  19. OXYTETRACYCLINE TABLETS
  20. OTC FUFANGGANMAOLINGPIAN
  21. DIPYRIDAMOLE TABLETS
  22. OTC FUMASUAN TONGTIFEN PIAN
  23. OTC HOUKANG SAN
  24. OTC WEI C YINQIAO PIAN
  25. OTC [Label in Foreign Language]
  26. XCQM XUECHA QINGMU
  27. YABANG GROUP CARBAZOCHROME TABLETS
  28. ZN MENADIOL DIACETATE TABLETS
  29. BAOZHUPAI® [Label in Foreign Language]
  30. TRIVITAMINS B TABLETS [as reflected in the package insert]
  31. HUANQIU OFLOXACIN EAR DROPS [as reflected in the primary packaging and package insert]
  32. PR® RACEANISODAMINE TABLETS
  33. Jingkang Jiaonang
  34. 1 YI LHENG
  35. OTC [Label in Foreign Language]
  36. AZITHROMYCIN DISPERSIBLE TABLETS
  37. OTC NAPHAZOLINE HYDROCHLORIDE, CHLORPHENAMINE MALEATE AND VITAMIN B12 EYE DROPS EYE SIGHT
  38. KOUQIANGYAN PENWUJI
  39. OTC NYTH
  40. OTC ACUTE BRONCHITIS SYRUP
  41. OTC HUAHONG® XIAOZHONGZHITONGDING
  42. YUNNAN BAIYAO JIAONANG
  43. LOMEFLOXACIN HYDROCHLORIDE EYE DROPS
  44. OTC [Label in Foreign Language] 
  45. OTC LORATADINE TABLETS [as reflected in the package insert]
  46. SPH DING LU BRAND® QINGGAN CHUANXINLIAN PIAN
  47. OTC 999® ZHENGTIAN WAN

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration and testing process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential danger or injury if administered.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ ereport. You may also call the Center for Drug Regulation and Research at telephone number (02)809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

Dissemination of the information to all concerned is requested.]

Attachment:-> FDA Advisory No. 2019-387

FDA Advisory No. 2019-386 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:

  1. OTC YUNNAN BAIYAO QIWUJI
  2. CISEN GENTAMICIN SULFATE INJECTION
  3. PANTOPRAZOLE SODIUM ENTERIC-COATED TABLETS
  4. YATAI® AZITHROMYCIN FOR INJECTION
  5. ERYTHROMYCIN ENTERIC-COATED TABLETS
  6. OTC NAOXINSHU KOUFUYE
  7. OTC YESUANPIAN [as reflected in the primary and secondary packaging]
    FOLIC ACID TABLET [as reflected in the package insert]
  1. OTC CETIRIZINE HYDROCHLORIDE TABLETS
  2. KANGMEI MCKIN VITAMIN C TABLET (WITH LEMON)
  3. KANGMEI MCKIN VITAMIN C TABLET (WITH BLUEBERRIES)
  4. C
  5. BIOHEK BAIHEKANG BRAND VITAMIN C LOZENGE
  6. HUAYI® DEXAMETHASONE SODIUM PHOSPHATE INJECTION
  7. DONGYAO ETHAMSYLATE INJECTION
  8. CEFOPERAZONE SODIUM AND SULBACTAM SODIUM FOR INJECTION
  9. SPECTINOMYCIN HYDROCHLORIDE FOR INJECTION
    [as reflected in the primary and secondary packaging-Vial]
    CISEN BENZYL ALCOHOL INJECTION
    [as reflected in the package insert-Ampoule]
  1. OTC QINGXUAN PIAN
  2. YATAI® ACICLOVIR FOR INJECTION
  3. OTC ZHIKEPIPA KELI
  4. SUXIAOJIUXINWAN
  5. XINYAXILE DANSHENZHUSHEYE
  6. ZHEN ZHU MING MU YAN BU HU LI YE
  7. 1 YI LHENG ZHUIFENGSHU JINGHUO XUEPIAN
  8. TONGREN DAHUOLUO WAN
  9. YANGXUE SHENGFA JIAONANG
  10. CNWM YOUGUI WAN
  11. CONBA JIXUEGANSHUANG RUANGAO
  12. YUSHANPAI LONGXUEJIE JIAONANG
  13. ORIGINAL® PEPPERMINT AQUA
  14. PIFUBING XUEDU WAN
  15. ZUYAXI FEBUXOSTAT TABLETS
  16. OTC CONCENTRATED TINIDAZOLE GARGLES
  17. VALACICLOVIR HYDROCHLORIDE TABLETS
  18. ACYCLOVIR EYE DROPS
  19. OTC NAPHAZOLINE HYDROCHLORIDE NASAL DROPS
  20. SINE® DICLOFENAC SODIUM SUSTAINED-RELEASE TABLETS
  21. XIAONUO NORFLOXACIN CAPSULES
  22. COMPOUND KETOCONAZOLE LOTION
  23. TINIDAZOLE AND SODIUM CHLORIDE INJECTION
  24. OTC NIN JIOM PEI PA KOA
  25. ROXITHROMYCIN TABLETS
  26. CEFUROXIME AXETIL TABLETS
  27. YATAI® PHENOXYMETHYLPENICILLIN POTASSIUM TABLETS
  28. YATAI®AMOXICILLIN CLAVULANATE POTASSIUM DISPERSIBLE TABLETS
  29. HALCINONIDE SOLUTION
  30. VITAMIN B6 INJECTION

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration and testing process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential danger or injury if administered.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02)809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No. 2019-386

FDA Advisory No. 2019-385-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga hindi rehistradong gamot na:

  1. OTC XIAOYAO WAN
  2. POTASSIUM CHLORIDE SUSTAINED-RELEASE TABLETS [as reflected in the package insert]
    DANGSHIPIAN [as reflected in the secondary packaging]
  1. CIMETIDINE INJECTION
  2. 999® C16H17N5O7S2 [as reflected in the primary packaging]
  3. XUEFU ZHUYU JIAONANG
  4. OTC TASLY® YANGXUE QINGNAO KELI
  5. OTC XIAOYAN TUIRE KELI
  6. OTC CONCENTRATED TINIDAZOLE GARGLES
  7. OTC FANGFENGTONGSHENGWAN
  8. QI LU AMIKACIN SULFATE INJECTION
  9. PROGESTERONE INJECTION
  10. VITAMIN C INJECTION
  11. CEFIXIME CAPSULES TOUBAOKEWO JIAONANG
  12. POTASSIUM CHLORIDE SUSTAINED-RELEASE TABLETS
  13. [LABEL IN FOREIGN LANGUAGE]
  14. MINGMU JILI WAN [as reflected in the package insert]
  15. CSPC YANGXUE SHENGFA JIAONANG
  16. XIAO YAN LI DAN PIAN
  17. LAITING PROGESTERONE SOFT CAPSULES
  18. SHENSHITONG KELI
  19. JINSUO GU JING WAN
  20. [LABEL IN FOREIGN LANGUAGE]
  21. OTC [LABEL IN FOREIGN LANGUAGE]
  22. LEVOFLOXACIN HYDROCHLORIDE AND SODIUM CHLORIDE INJECTION
  23. GLUCOSE INJECTION 5%
  24. LEVOFLOXACIN LACTATE AND SODIUM CHLORIDE INJECTION
  25. SODIUM CHLORIDE INJECTION 0.9%
  26. OTC PIEN TZE HUANG® HUO XIANG ZHENG QI SHUI
  27. HASEN INOSINE INJECTION
  28. FUFANG ANLIN BABITUO ZHUSHEYE
  29. HASEN CHLORPHENAMINE MALEATE INJECTION
  30. OTC BANLANGEN KELI
  31. OTC YINGIAO JIEDU KELI
  32. [LABEL IN FOREIGN LANGUAGE]
  33. OTC NIUHUANGSHANGQINGPIAN
  34. OTC 999®
  35. CARSICK TAPE
  36. YATAI® AMOXICILLIN CAPSULES
  37. YATAI® CEFTRIAXONE SODIUM FOR INJETION
  38. YATAI® CEFALEXIN CAPSULES
  39. OTC FUFANG LUOHANGUO ZHIKE KELI
  40. OTC DONG LING CAO PIAN
  41. OTC WU SHI CHA KE LI
  42. YU LONG MINIAONING CAPSULE
  43. OTC SHENGMAI YIN (DANG SHEN FANG)
  44. YABAO NIUHUANG JIEDU PIAN
  45. OTC HUMANWELL HEALTHCARE [as reflected in the secondary packaging]
  46. OTC XUANMEI GANJIE KELI

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang nasabing mga gamot ay hindi dumaan sa proseso ng rehistrasyon o pag-eeksamin ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Samakatuwid, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Ang nasabing mga iligal na produkto ay maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang publiko ay pinapaalalahanang huwag bumili ng nasabing mga iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing mga iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang mga produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facilityeReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: www.fda.gov.ph/adr-report-new at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:-> FDA Advisory No. 2019-385-A

FDA Advisory No. 2019-385 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:

  1. OTC XIAOYAO WAN
  2. POTASSIUM CHLORIDE SUSTAINED-RELEASE TABLETS [as reflected in the package insert]
    DANGSHIPIAN [as reflected in the secondary packaging]
  1. CIMETIDINE INJECTION
  2. 999® C16H17N5O7S2 [as reflected in the primary packaging]
  3. XUEFU ZHUYU JIAONANG
  4. OTC TASLY® YANGXUE QINGNAO KELI
  5. OTC XIAOYAN TUIRE KELI
  6. OTC CONCENTRATED TINIDAZOLE GARGLES
  7. OTC FANGFENGTONGSHENGWAN
  8. QI LU AMIKACIN SULFATE INJECTION
  9. PROGESTERONE INJECTION
  10. VITAMIN C INJECTION
  11. CEFIXIME CAPSULES TOUBAOKEWO JIAONANG
  12. POTASSIUM CHLORIDE SUSTAINED-RELEASE TABLETS
  13. [LABEL IN FOREIGN LANGUAGE]
  14. MINGMU JILI WAN [as reflected in the package insert]
  15. CSPC YANGXUE SHENGFA JIAONANG
  16. XIAO YAN LI DAN PIAN
  17. LAITING PROGESTERONE SOFT CAPSULES
  18. SHENSHITONG KELI
  19. JINSUO GU JING WAN
  20. [LABEL IN FOREIGN LANGUAGE]
  21. OTC [LABEL IN FOREIGN LANGUAGE]
  22. LEVOFLOXACIN HYDROCHLORIDE AND SODIUM CHLORIDE INJECTION
  23. GLUCOSE INJECTION 5%
  24. LEVOFLOXACIN LACTATE AND SODIUM CHLORIDE INJECTION
  25. SODIUM CHLORIDE INJECTION 0.9%
  26. OTC PIEN TZE HUANG® HUO XIANG ZHENG QI SHUI
  27. HASEN INOSINE INJECTION
  28. FUFANG ANLIN BABITUO ZHUSHEYE
  29. HASEN CHLORPHENAMINE MALEATE INJECTION
  30. OTC BANLANGEN KELI
  31. OTC YINGIAO JIEDU KELI
  32. [LABEL IN FOREIGN LANGUAGE]
  33. OTC NIUHUANGSHANGQINGPIAN
  34. OTC 999®
  35. CARSICK TAPE
  36. YATAI® AMOXICILLIN CAPSULES
  37. YATAI® CEFTRIAXONE SODIUM FOR INJETION
  38. YATAI® CEFALEXIN CAPSULES
  39. OTC FUFANG LUOHANGUO ZHIKE KELI
  40. OTC DONG LING CAO PIAN
  41. OTC WU SHI CHA KE LI
  42. YU LONG MINIAONING CAPSULE
  43. OTC SHENGMAI YIN (DANG SHEN FANG)
  44. YABAO NIUHUANG JIEDU PIAN
  45. OTC HUMANWELL HEALTHCARE [as reflected in the secondary packaging]
  46. OTC XUANMEI GANJIE KELI

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration and testing process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential danger or injury if administered.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02)809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No. 2019-385

FDA Advisory No. 2019-384-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga hindi rehistradong gamot na:

  1. OTC QING HUO PIAN
  2. MIAOYAO JIAOQIWANG SHADUKANG PENJI
  3. JIANGXI MINJI XIAN ZHU LI
  4. OTC FANGFENG TONGSHENG WAN
  5. GUI ZHI FU LING WAN
  6. OTC TAIJI® SANLIETONG COMPOUND PARACETAMOL TABLETS (II)
  7. OTC FOLIC ACID TABLETS [as reflected in the Package Insert]
  8. ROXITHROMYCIN TABLETS
  9. OTC MILIAN CHUANBEI PIPA GAO
  10. NANCHANG® [Label in Foreign Language]
  11. OTC NONGSUOWAN MAIWEI DIHUANGWAN
  12. PANTUO LAZUONA CHANGRONGPIAN
  13. OTC SHENG MAI YIN (DANG SHEN FANG)
  14. QINGLIN KELI [as reflected in the Package Insert]
  15. RIBAVIRIN INJECTION
  16. OTC [Label in Foreign Language]
  17. PIDI® COLCHICINE TABLETS
  18. OTC CNWM XIONGDAN ZHILING SHUAN
  19. [Label in Foreign Language]
  20. OTC CICLOPIROX OLAMINE CREAM [as reflected in the Package Insert]
  21. OMEPRAZOLE ENTERIC CAPSULE
  22. OTC TIAOJING ZHITONG JIAONANG [as reflected in the Package Insert]
  23. NUO FU SHA XING JIAONANG
  24. DA NING TANG LIAN QIAO BAI DU PIAN
  25. OTC QINGYUAN CALCIUM GLUCONATE TABLETS
  26. BAI NIAN SAN WEI
  27. CHUZHI SHENGFA PIAN
  28. OTC ZEYSUB® [Label in Foreign Language]
  29. OTC QUAN LU WAN
  30. TIANRANCAOBENPEIFANG YIGANERJING
  31. OTC LORATADINE TABLETS
  32. OTC SUL FUR OINTMENT [as reflected in the Primary Packaging]
  33. OTC LACONCORDE NAPHAZOLINE HYDROCHLORIDE, CHLORPHENAMINE MALEATE AND VITAMIN B12 EYE DROPS (CONTAINING SODIUM HYALURONATE)
  34. OTC BUSHEN QIANGSHEN JIAONANG
  35. OTC [Label in Foreign Language]
  36. OTC [Label in Foreign Language]
  37. [Label in Foreign Language]
  38. RHINITIS SPRAY
  39. WEI A NING HERBACEOUS EXTRACTION ANTIBACTERIAL
  40. OTC SANJIN® PIAN
  41. OTC [Label in Foreign Language]
  42. [Label in Foreign Language]
  43. OTC GLYCERINE ENEMA
  44. ZJIACHMEI LANG DU JUN E JING

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang nasabing mga gamot ay hindi dumaan sa proseso ng rehistrasyon o pag-eeksamin ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Samakatuwid, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Ang nasabing mga iligal na produkto ay maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang publiko ay pinapaalalahanang huwag bumili ng nasabing mga iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing mga iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang mga produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facilityeReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: www.fda.gov.ph/adr-report-new at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:-> FDA Advisory No. 2019-384-A

FDA Advisory No. 2019-384 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:

  1. OTC QING HUO PIAN
  2. MIAOYAO JIAOQIWANG SHADUKANG PENJI
  3. JIANGXI MINJI XIAN ZHU LI
  4. OTC FANGFENG TONGSHENG WAN
  5. GUI ZHI FU LING WAN
  6. OTC TAIJI® SANLIETONG COMPOUND PARACETAMOL TABLETS (II)
  7. OTC FOLIC ACID TABLETS [as reflected in the Package Insert]
  8. ROXITHROMYCIN TABLETS
  9. OTC MILIAN CHUANBEI PIPA GAO
  10. NANCHANG® [Label in Foreign Language]
  11. OTC NONGSUOWAN MAIWEI DIHUANGWAN
  12. PANTUO LAZUONA CHANGRONGPIAN
  13. OTC SHENG MAI YIN (DANG SHEN FANG)
  14. QINGLIN KELI [as reflected in the Package Insert]
  15. RIBAVIRIN INJECTION
  16. OTC [Label in Foreign Language]
  17. PIDI® COLCHICINE TABLETS
  18. OTC CNWM XIONGDAN ZHILING SHUAN
  19. [Label in Foreign Language]
  20. OTC CICLOPIROX OLAMINE CREAM [as reflected in the Package Insert]
  21. OMEPRAZOLE ENTERIC CAPSULE
  22. OTC TIAOJING ZHITONG JIAONANG [as reflected in the Package Insert]
  23. NUO FU SHA XING JIAONANG
  24. DA NING TANG LIAN QIAO BAI DU PIAN
  25. OTC QINGYUAN CALCIUM GLUCONATE TABLETS
  26. BAI NIAN SAN WEI
  27. CHUZHI SHENGFA PIAN
  28. OTC ZEYSUB® [Label in Foreign Language]
  29. OTC QUAN LU WAN
  30. TIANRANCAOBENPEIFANG YIGANERJING
  31. OTC LORATADINE TABLETS
  32. OTC SUL FUR OINTMENT [as reflected in the Primary Packaging]
  33. OTC LACONCORDE NAPHAZOLINE HYDROCHLORIDE, CHLORPHENAMINE MALEATE AND VITAMIN B12 EYE DROPS (CONTAINING SODIUM HYALURONATE)
  34. OTC BUSHEN QIANGSHEN JIAONANG
  35. OTC [Label in Foreign Language]
  36. OTC [Label in Foreign Language]
  37. [Label in Foreign Language]
  38. RHINITIS SPRAY
  39. WEI A NING HERBACEOUS EXTRACTION ANTIBACTERIAL
  40. OTC SANJIN® PIAN
  41. OTC [Label in Foreign Language]
  42. [Label in Foreign Language]
  43. OTC GLYCERINE ENEMA
  44. ZJIACHMEI LANG DU JUN E JING

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration and testing process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential danger or injury if administered.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the

Center for Drug Regulation and Research at telephone number (02)809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No. 2019-384

FDA Advisory No. 2019-381-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga hindi rehistradong gamot na:

1. Methyl Salicylate + Camphor + Menthol (Milagrosa Herbal Oil) 125ml
2. Irish Pain Killer Extra Strength Herbal Liniment 150ml
3. Methyl Salicylate + Camphor + Menthol (Kung Fu) Topical Pain Reliever 25ml

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang nasabing mga gamot ay hindi dumaan sa proseso ng rehistrasyon o pag-eeksamin ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Samakatuwid, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Ang nasabing mga iligal na produkto ay maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang publiko ay pinapaalalahanang huwag bumili ng nasabing iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facility, eReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 809- 5596. Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: www.fda.gov.ph/adr-report-new at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:-> FDA Advisory No. 2019-381-A

FDA Advisory No. 2019-381 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug product:

1. Methyl Salicylate + Camphor + Menthol (Milagrosa Herbal Oil) 125ml
2. Irish Pain Killer Extra Strength Herbal Liniment 150ml
3. Methyl Salicylate + Camphor + Menthol (Kung Fu) Topical Pain Reliever 25ml

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration and testing process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential danger or injury if administered.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the aboveidentified violative drug product until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02)809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:->FDA Advisory No. 2019-381

FDA Advisory No. 2019-380-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga hindi rehistradong gamot na:

1. Kens Power Kens Mangosteen Power Liniment 60ml
2. Silverscent Herbal Liniment Oil 30ml
3. New! Improved! Power Plus Herbal Linement Oil With Mangosteen Extract Extra Strenght 60ml
4. Methysalicylate + Menthol + Camphor (Panyawan & Ginseng Oil) 25ml

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang nasabing mga gamot ay hindi dumaan sa proseso ng rehistrasyon o pageeksamin ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Samakatuwid, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Ang nasabing mga iligal na produkto ay maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang publiko ay pinapaalalahanang huwag bumili ng nasabing iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facility, eReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 809- 5596. Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: www.fda.gov.ph/adr-report-new at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:-> FDA Advisory No. 2019-380-A

FDA Advisory No. 2019-380 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:

1. Kens Power Kens Mangosteen Power Liniment 60ml
2. Silverscent Herbal Liniment Oil 30ml
3. New! Improved! Power Plus Herbal Linement Oil With Mangosteen Extract Extra Strenght 60ml
4. Methysalicylate + Menthol + Camphor (Panyawan & Ginseng Oil) 25ml

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration and testing process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential danger or injury if administered.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the aboveidentified violative drug product until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02)809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No. 2019-380

FDA Advisory No. 2019-379-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na “Methyl Salicylate + Menthol + Camphor (Shanne Liniment) 120ml”

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng hindi rehistradong gamot na:

  1. Methyl Salicylate + Menthol + Camphor (Shanne Liniment) 120ml

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon o pageeksamin ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Samakatuwid, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Ang nasabing iligal na produkto ay maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang publiko ay pinapaalalahanang huwag bumili ng nasabing iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facility, eReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 809- 5596. Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: www.fda.gov.ph/adr-report-new at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:-> FDA Advisory No. 2019-379-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-379-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na “Methyl Salicylate + Menthol + Camphor (Shanne Liniment) 120ml”

FDA Advisory No. 2019-379 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product “Methyl Salicylate + Menthol + Camphor (Shanne Liniment) 120ml”

The Food and Drug Administration (FDA) advises the public against the purchase and use of the unregistered drug product:

  1. Methyl Salicylate + Menthol + Camphor (Shanne Liniment) 120ml

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug product has not gone through the registration and testing process of the Agency and has not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. The consumption of such violative product may pose potential danger or injury if administered.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the aboveidentified violative drug product until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02)809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No. 2019-379

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-379 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product “Methyl Salicylate + Menthol + Camphor (Shanne Liniment) 120ml”