Category: Drugs Advisories

FDA Advisory No. 2020-186 || 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. Irish Pain Killer Extra Strength
  2. MD® Skin Fighter 8g
  3. Ong Hit Thong Mui

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. Therefore, consumption of such violative product may pose potential danger or injury to health.

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) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is request.

Attachment:-> FDA Advisory No.2020-186

FDA Advisory No. 2020-185-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Tretinoin (UK Derm Erase) 20 ml

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

  1. Tretinoin (UK Derm Erase) 20 ml

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 pekeng 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) 8809-5596. Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

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

Attachment:->FDA Advisory No.2020-185-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-185-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Tretinoin (UK Derm Erase) 20 ml

FDA Advisory No. 2020-185 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Tretinoin (UK Derm Erase) 20ml

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

  1. Tretinoin (UK Derm Erase) 20ml

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. Therefore, consumption of such violative product may pose potential danger or injury to health.

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) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:->FDA Advisory No.2020-185

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-185 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Tretinoin (UK Derm Erase) 20ml

FDA Advisory No. 2020-184-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. Gastropin with Belladonna Tablet 120’s
  2. Ancom Tablets Anti-Hypertensive Compound Tablet 100’s
  3. Shilintong Tablets 100’s

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 pekeng 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) 8809-5596. Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

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

Attachment:-> FDA Advisory No.2020-184-A

FDA Advisory No. 2020-184 || 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. Gastropin with Belladonna Tablet 120’s
  2. Ancom Tablets Anti-Hypertensive Compound Tablet 100’s
  3. Shilintong Tablets 100’s

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. Therefore, consumption of such violative product may pose potential danger or injury to health.

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) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is request.

Attachment:-> FDA Advisory No.2020-184

FDA Advisory No. 2020-183-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Rheumason® Green Balm® 20g

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

  1. Rheumason® Green Balm® 20g

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 pekeng 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) 8809-5596. Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

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

Attachment:-> FDA Advisory No.2020-183-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-183-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Rheumason® Green Balm® 20g

FDA Advisory No. 2020-183 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Rheumason® Green Balm® 20g

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

  1. Rheumason® Green Balm® 20g

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. Therefore, consumption of such violative product may pose potential danger or injury to health.

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) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-183

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-183 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Rheumason® Green Balm® 20g

FDA Advisory No. 2020-182-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Methyl Salicylate Camphor + Menthol (Megaplas Liniment Oil) 25 mL

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

  1. Methyl Salicylate Camphor + Menthol (Megaplas Liniment Oil) 25 mL

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 pekeng 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) 8809-5596. Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

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

Attachment:-> FDA Advisory No.2020-182-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-182-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Methyl Salicylate Camphor + Menthol (Megaplas Liniment Oil) 25 mL

FDA Advisory No. 2020-182 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Methyl Salicylate Camphor + Menthol (Megaplas Liniment Oil) 25 mL

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

  1. Methyl Salicylate Camphor + Menthol (Megaplas Liniment Oil) 25 mL

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. Therefore, consumption of such violative product may pose potential danger or injury to health.

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) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-182

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-182 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Methyl Salicylate Camphor + Menthol (Megaplas Liniment Oil) 25 mL

FDA Advisory No. 2020-181-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Green Nature Super Rub with Bee Propolis 20gms

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

  1. Green Nature Super Rub with Bee Propolis 20gms

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 pekeng 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) 8809-5596. Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

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

Attachment:-> FDA Advisory No.2020-181-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-181-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Green Nature Super Rub with Bee Propolis 20gms

FDA Advisory No. 2020-181 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Green Nature Super Rub with Bee Propolis 20gms

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

  1. Green Nature Super Rub with Bee Propolis 20gms

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. Therefore, consumption of such violative product may pose potential danger or injury to health.

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) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-181

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-181 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Green Nature Super Rub with Bee Propolis 20gms

FDA Advisory No. 2020-180-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. Methergin® (Methylergometrine) 0.125mg Sugar Coated Tablet
  2. Valium® (Diazepam) 10mg Tablet

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 pekeng 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) 8809-5596. Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

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

Attachment:-> FDA Advisory No.2020-180-A

FDA Advisory No. 2020-180 || 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. Methergin® (Methylergometrine) 0.125mg Sugar Coated Tablet
  2. Valium® (Diazepam) 10mg Tablet

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. Therefore, consumption of such violative product may pose potential danger or injury to health.

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) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-180

FDA Advisory No. 2020-179-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 hindi rehistadong mga gamot na:

  1. Agua Oxigenada F.E.U. XIV-10 Vols 120mL
  2. Agua Oxigenada F.E.U. XIV-10 Vols 60mL
  3. Jspher Lyn’s Marketing Aciete De Manzanilla 25mL.
  4. Extra Strength Methyl Salicylate Camphor + Menthol (Efficasient Oil Liniment) 25mL
  5. Tincture of Benzalkonium Chloride 25m1
  6. Jspher Pure Acetone 25mL.
  7. New Improved Bio-Magsoncent Liniment Oil 120 mL
  8. Magson Herbal Oil 120 mL
  9. Kris Haplas Herbal Oil 60 mL
  10. Extra Strength (Superscent Oil) 50mL.

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang mga 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). Gayundin, ang kani-kanilang taga-gawa at taga-pamahagi ay hindi lisensyado sa FDA. Samakatuwid, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Ang nasabing iligal na mga 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 mga nasabing iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang mga 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/a 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 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 pekeng 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) 8809-5596. Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon

Attachment:-> FDA Advisory No.2020-179-A

FDA Advisory No. 2020-179 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

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

  1. Agua Oxigenada F.E.U. XIV-10 Vols 120mL
  2. Agua Oxigenada F.E.U. XIV-10 Vols 60mL
  3. Jspher Lyn’s Marketing Aciete De Manzanilla 25mL.
  4. Extra Strength Methyl Salicylate Camphor + Menthol (Efficasient Oil Liniment) 25mL
  5. Tincture of Benzalkonium Chloride 25m1
  6. Jspher Pure Acetone 25mL.
  7. New Improved Bio-Magsoncent Liniment Oil 120 mL
  8. Magson Herbal Oil 120 mL
  9. Kris Haplas Herbal Oil 60 mL
  10. Extra Strength (Superscent Oil) 50mL.

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. Likewise their respective manufacturers and distributors have not also been licensed by FDA. Thus, the Agency cannot guarantee their quality and safety. Therefore, consumption of such violative products may pose potential danger or injury to health.

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 have 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) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-179

FDA Advisory No. 2020-176-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. Crocodile Trademark For Asthma 30 Tablets
  2. Primary packaging: Ling Nam Ultra Balm 20 ml Secondary packaging: Ultra Balm 20 ml
  3. SANJIN Watermelon Frost 3g
  4. Jinling Superior Yinchiao Tablet (Chiehtupien) 120 Tabs
  5. Buddha Brand Yee Tin Medical Oil 30 ml
  6. Tortoise Snake Itch Discharge Toxin Clearing Pills 48’s
  7. Oren Herb Sperm – Endengering Pills 150’s
  8. DK New Generation Menopause Pill 100’s
  9. Tasly Compound Danshen Dripping Pills 180 pellets
  10. Cold Analgesic Gel Counterpain Cool® 60 grams
  11. DANSN Gan Mao Tong Film-Coated Tablets 24’s
  12. Golden Throat Lozenge 24g
  13. BJ Boje® Enema 20cc x 2
  14. Golden Cane-Sugar Free Golden Throat Candy 12’s
  15. Sumgel Enema “Aid” 20cc x 10
  16. DK Tonifying Lung Capsule 30’s
  17. Green Balm Mosquito Brand
  18. Polar Bear Brand Essential Embrocation 18ml
  19. KULIN BrandLaryngitis Pills 30’s
  20. OTC Fenbid® Ibuprofen Sustained-released Capsules 20’s
  21. MD® Pain Fighter Unisex 6 Patches

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang mga 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 mga 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 mga nasabing iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang mga 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 pekeng 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) 8809-5596. Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon

Attachment:-> FDA Advisory No.2020-176-A

FDA Advisory No. 2020-176 || 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. Crocodile Trademark For Asthma 30 Tablets
  2. Primary packaging : Ling Nam Ultra Balm 20ml Secondary packaging: Ultra Balm 20 ml
  3. SANJIN Watermelon Frost 3g
  4. Jinling Superior Yinchiao Tablet (Chiehtupien) 120 Tabs
  5. Buddha Brand Yee Tin Medical Oil 30 ml
  6. Tortoise Snake Itch Discharge Toxin Clearing Pills 48’s
  7. Oren Herb Sperm – Endengering Pills 150’s
  8. DK New Generation Menopause Pill 100’s
  9. Tasly Compound Danshen Dripping Pills 180 pellets
  10. Cold Analgesic Gel Counterpain Cool® 60 grams
  11. DANSN Gan Mao Tong Film-Coated Tablets 24’s
  12. Golden Throat Lozenge 24g
  13. BJ Boje® Enema 20cc x 2
  14. Golden Cane-Sugar Free Golden Throat Candy 12’s
  15. Sumgel Enema “Aid” 20cc x 10
  16. DK Tonifying Lung Capsule 30’S
  17. Green Balm Mosquito Brand
  18. Polar Bear Brand Essential Embrocation 18ml
  19. KULIN Brand Laryngitis Pills 30’s
  20. OTC Fenbid® Ibuprofen Sustained-released Capsules 20’s
  21. MD® Pain Fighter Unisex 6 Patches

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. Therefore, consumption of such violative products may pose potential danger or injury to health.

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) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-176

FDA Advisory No. 2020-155-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. Chuan Chiong Liu Wei Di Huang Wan (Concentrated Pill) 240 Pills
  2. Chuan Chiong Liu Wei Di Huang
  3. Growful “204” Wei Te Ling

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 iligal na mga 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 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)8809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

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

Attachment:->FDA Advisory No.2020-155-A

FDA Advisory No. 2020-155 || 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. Chuan Chiong Liu Wei Di Huang Wan (Concentrated Pill) 240 Pills
  2. Chuan Chiong Liu Wei Di Huang
  3. Growful “204” Wei Te Ling

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug product 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. Therefore consumption of such violative products may pose potential danger or injury to health.

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)8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link:https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-155

FDA Advisory No. 2020-154-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

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

  1. Pagkabuhay Herbal Healing Oil 60ml
  2. H. Ginger Herbal Healing Oil 60ml    
  3. H. Eucalyptmint with Peppermint Herbal Healing Oil All Natural 60ml
  4. H. Ginger Herbal Healing Vicks
  5. Pagkabuhay Herbal Healing Vicks

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) 8809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primary reporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

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

Attachment:-> FDA Advisory No.2020-154-A

FDA Advisory No. 2020-154 || 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. Pagkabuhay Herbal Healing Oil 60ml
  2. H. Ginger Herbal Healing Oil 60ml    
  3. H. Eucalyptmint with Peppermint Herbal Healing Oil All Natural 60ml
  4. H. Ginger Herbal Healing Vicks
  5. Pagkabuhay Herbal Healing Vicks

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) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-154

FDA Advisory No. 2020-153-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Agua (Cleansing Solution) 60mL

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

  1. Agua (Cleansing Solution) 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 pekeng 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) 8809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primaryreporting.who-umc.org/ Reporting/Reporter? OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

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

Attachment:-> FDA Advisory No.2020-153-A

FDA Advisory No. 2020-153 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Agua (Cleansing Solution) 60mL

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

  1. Agua (Cleansing Solution) 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. Therefore, consumption of such violative product may pose potential danger or injury to health.

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) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-153

FDA Advisory No. 2020-152-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Family Care™ Original Strength Bacitracin First Aid Antibiotic Ointment USP 0.5 oz (14g)

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

  1. Family Care Original Strength Bacitracin First Aid Antibiotic Ointment USP 0.5 oz (14g)

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 pekeng 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) 8809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primaryreporting.who-umc.org/ Reporting/Reporter? OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

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

Attachment:-> FDA Advisory No.2020-152-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-152-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Family Care™ Original Strength Bacitracin First Aid Antibiotic Ointment USP 0.5 oz (14g)

FDA Advisory No. 2020-152 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Family Care™ Original Strength Bacitracin First Aid Antibiotic Ointment USP 0.5 oz (14g)

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

  1. Family Care  Original Strength Bacitracin First Aid Antibiotic Ointment USP 0.5 oz (14g)

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) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-152

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-152 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Family Care™ Original Strength Bacitracin First Aid Antibiotic Ointment USP 0.5 oz (14g)

FDA Advisory No. 2020-151-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Methyl Salicylate (Georgine Magson Herbal Oil) 60ml

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

  1. Methyl Salicylate (Georgine Magson Herbal Oil) 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) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-151-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-151-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Methyl Salicylate (Georgine Magson Herbal Oil) 60ml

FDA Advisory No. 2020-151 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Methyl Salicylate (Georgine Magson Herbal Oil) 60ml

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

  1. Methyl  Salicylate  (Georgine Magson Herbal Oil) 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) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-151

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-151 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Methyl Salicylate (Georgine Magson Herbal Oil) 60ml

FDA Advisory No. 2020-150-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 10%100ml (Bio-Magscent Plus) 60ml
  2. Salicylic Acid 10g / 5% 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 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) 8809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primary reporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

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

Attachment:->FDA Advisory No.2020-150-A

FDA Advisory No. 2020-150 || 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. Methyl Salicylate 10%100ml (Bio-Magscent Plus) 60ml
  2. Salicylic Acid 10g / 5% 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 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) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:->FDA Advisory No.2020-150

FDA Advisory No. 2020-149-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Bayer Cyproterone acetate 2mg – Ethinylestradiol 0.035 mg (Diane®- 35) Tablet

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

  1. Bayer Cyproterone acetate 2mg – Ethinylestradiol 0.035 mg (Diane®- 35) Tablet

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)8809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

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

Attachment:->FDA Advisory No.2020-149-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-149-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Bayer Cyproterone acetate 2mg – Ethinylestradiol 0.035 mg (Diane®- 35) Tablet
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