Category: Drugs Advisories

FDA Advisory No. 2020-1687 || 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 H51021671 [Label in Foreign Language]
  2. OTC Yansuan Xiujixin Pian
  3. OTC Wepon® Bromhexine Hydrochloride Tablets
  4. OTC Guo Hua® HNGH Tian Ma Shou Wu Pian
  5. Fufang Dantong Pian

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the Agency and 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.

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]. 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.2020-1687

FDA Advisory No. 2020-1686-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 Compound Vitamin B Tablets
  2. OTC Miaoshou® Vitamin B6 Tablets
  3. Shilintongpian
  4. Zhendong® Guang An Suan Pian
  5. Lee Buan Soa Pill (Fishing Brand) 50 pills

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

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

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]. 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.2020-1686-A

FDA Advisory No. 2020-1686 || 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 Compound Vitamin B Tablets
2. OTC Miaoshou® Vitamin B6 Tablets
3. Shilintongpian
4. Zhendong® Guang An Suan Pian
5. Lee Buan Soa Pill (Fishing Brand) 50 pills

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the Agency and 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.

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]. 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.2020-1686

FDA Advisory No. 2020-1685-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

1. OTC Inosine Tablets
2. OTC Yuanhu Zhitong Pian
3. H44023966 [Label in Foreign Language]
4. Moroxydine Hydrochloride Tablets 0.1g
5. OTC Vitamin C Tablets

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

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

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]. 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.2020-1685-A

FDA Advisory No. 2020-1685 || 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 Inosine Tablets
2. OTC Yuanhu Zhitong Pian
3. H44023966 [Label in Foreign Language]
4. Moroxydine Hydrochloride Tablets 0.1g
5. OTC Vitamin C Tablets

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the Agency and 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.

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]. 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.2020-1685

FDA Advisory No. 2020-1684-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 Miaoshou® Vitamin B2 Tablets
2. OTC Z35020252 [Label in Foreign Language]
3. WY® Metamizole Sodium Tablets 0.5g
4. OTC Houtoujun Pian
5. OTC Cimetidine Tablets

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

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

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]. 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.2020-1684-A

FDA Advisory No. 2020-1684 ||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 Miaoshou® Vitamin B2 Tablets
2. OTC Z35020252 [Label in Foreign Language]
3. WY® Metamizole Sodium Tablets 0.5g
4. OTC Houtoujun Pian
5. OTC Cimetidine Tablets

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the Agency and 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.

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] 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.2020-1684

FDA Advisory No. 2020-1683-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 Chlorphenamine Maleate Tablets
2. Cusuan Ponisong Pian
3. Nysfungin Tablets
4. OTC H21022140 [Label in Foreign Language]
5. SPH Ding Lu Brand® Haizhu Chuanxiding Pian

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

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

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]. 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.2020-1683-A

FDA Advisory No. 2020-1683 || 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 Chlorphenamine Maleate Tablets
2. Cusuan Ponisong Pian
3. Nysfungin Tablets
4. OTC H21022140 [Label in Foreign Language]
5. SPH Ding Lu Brand® Haizhu Chuanxiding Pian

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the Agency and 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.

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]. 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.2020-1683

FDA Advisory No. 2020-1682-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 She Dan Chuan Bei Ye 10mL
2. Zhennaoning Jiaonang
3. OTC Compound Flavescent Sophora and Salicylic Acid Powder Fufang Kushen Shuiyangsuan San [as reflected in the secondary packaging]
4. Sanqi Shangyao Pian
5. Coenzyme A for Injection

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

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

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]. 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.2020-1682-A

FDA Advisory No. 2020-1682 || 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 She Dan Chuan Bei Ye 10mL
2. Zhennaoning Jiaonang
3. OTC Compound Flavescent Sophora and Salicylic Acid Powder Fufang Kushen Shuiyangsuan San [as reflected in the secondary packaging]
4. Sanqi Shangyao Pian [as reflected in the package insert]
5. Coenzyme A for Injection

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration 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 its quality, safety and efficacy. 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.

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]. 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.2020-1682

FDA Advisory No. 2020-1681-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. Citiconline Sodium Injection 2ml:0.25g
2. Xian Zhu Li 15mL
3. Shenmai Zhusheye 10mL [as reflected in the package insert]
4. [Label in Foreign Language]
5. Hasen® Cimetidine Injection 2ml:0.2g

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

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

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]. 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.2020-1681-A

FDA Advisory No. 2020-1681 || 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. Citiconline Sodium Injection 2ml:0.25g
2. Xian Zhu Li 15mL
3. Shenmai Zhusheye 10mL [as reflected in the package insert]
4. [Label in Foreign Language]
5. Hasen® Cimetidine Injection 2ml:0.2g

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration 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 its quality, safety and efficacy. 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.

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]. 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.2020-1681

 

FDA Advisory No. 2020-1680-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.CISEN® Fluconazole and Sodium Chloride Injection 100ml:0.2g:0.9g
2. OTC Loratadine Syrup 60mL
3. OTC Chuanbei Qingfeitangjiang
4. Lysine Acetylsalicylate for Injection 0.9g
5. Raceanisodamine Hydrochloride Injection 1ml : 10mg

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

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

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]. 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.2020-1680-A

FDA Advisory No. 2020-1680 || 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. CISEN® Fluconazole and Sodium Chloride Injection 100ml:0.2g:0.9g
2. OTC Loratadine Syrup 60mL
3. OTC Chuanbei Qingfeitangjiang
4. Lysine Acetylsalicylate for Injection 0.9g
5. Raceanisodamine Hydrochloride Injection 1ml : 10mg

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration 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 its quality, safety and efficacy. 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.

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]. 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.

Attachement–>FDA-Advisory-No.2020-1680

FDA Advisory No. 2020-1617-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. Shenglingcao™ Shirunshaoshang 18g
2. OTC Shaotangshang Gao
3. Fuyankang Pian 0.25g
4. KBN® Cefixime Capsules 100mg
5. OTC Tianma Jiaonang

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

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

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]. 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.2020-1617-A

FDA Advisory No. 2020-1617 || 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. Shenglingcao™ Shirunshaoshang 18g
2. OTC Shaotangshang Gao
3. Fuyankang Pian 0.25g
4. KBN® Cefixime Capsules 100mg
5. OTC Tianma Jiaonang

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the Agency and 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.

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]. 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.2020-1617

FDA Advisory No. 2020-1616-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 Bohetong Xiruji
2. Santen Sante FX 12ml
3. OTC Clotrimazole Solution 8ml
4. OTC Chenxiang Lubailu Pian

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

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

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]. 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.2020-1616-A

FDA Advisory No. 2020-1616 || 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 Bohetong Xiruji
2. Santen Sante FX 12ml
3. OTC Clotrimazole Solution 8ml
4. OTC Chenxiang Lubailu Pian

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the Agency and 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.

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]. 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.2020-1616

FDA Advisory No. 2020-1615-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. Cisen® Levofloxacin Hydrochloride Eye Drops – Yansuan Zuoyangfushaxing Diyanye
2. OTC Ranitidine Hydrochloride Capsules
3. Label in foreign language
4. BF® Fusidic Acid Cream 10g
5. Smecta® Montmorillonite Powder 3g

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

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

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]. 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.2020-1615-A

FDA Advisory No. 2020-1615 || 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. Cisen® Levofloxacin Hydrochloride Eye Drops – Yansuan Zuoyangfushaxing Diyanye
2. OTC Ranitidine Hydrochloride Capsules
3. Label in foreign language
4. BF® Fusidic Acid Cream 10g
5. Smecta® Montmorillonite Powder 3g

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the Agency and 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.

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]. 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.2020-1615

FDA Advisory No. 2020-1614-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 Salicylic Acid and Phenol Plasters
2. TL® Allopurinol 0.1g Tablet
3. Compound Reserpine and Triamterene Tablets – Fufang Lixueping Anbendieding Pian
4. OTC ZSM Siwei Zhenceng Bingpeng Diyanye (as reflected in the package insert)
5. OTC Montmorillonite Powder

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

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

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]. 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.2020-1614-A

FDA Advisory No. 2020-1614 || 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 Salicylic Acid and Phenol Plasters
2. TL® Allopurinol 0.1g Tablet
3. Compound Reserpine and Triamterene Tablets – Fufang Lixueping Anbendieding Pian
4. OTC ZSM Siwei Zhenceng Bingpeng Diyanye (as reflected in the package insert)
5. OTC Montmorillonite Powder

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the Agency and 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.

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]. 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.2020-1614

FDA Advisory No. 2020-1613-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. Ruhe Sanjie Tablets
2. Vitamin E (as reflected in the secondary packaging)
YangShengTang Natural Vitamin E Soft Capsules
(as reflected in the primary packaging)
3. Fengshiding Jiaonang (as reflected in the package insert)
4. OTC Zu Guang San

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

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

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]. 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.2020-1613-A

FDA Advisory No. 2020-1613 || 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. Ruhe Sanjie Tablets
2. Vitamin E (as reflected in the secondary packaging)
YangShengTang Natural Vitamin E Soft Capsules
(as reflected in the primary packaging)
3. Fengshiding Jiaonang (as reflected in the package insert)
4. OTC Zu Guang San

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the Agency and 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.

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]. 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.2020-1613

FDA Advisory No. 2020-1612-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 Naoxinshu Koufuye
2. Apollo® Hericium Erinaceus Super-Quality Healthy Oral Liquid
3. Label in foreign language
4. Wo Hong Tong Double Action Bai Fung Pills
5. Thousand Oil 45g

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

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

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]. 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.2020-1612-A

FDA Advisory No. 2020-1612 || 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 Naoxinshu Koufuye
2. Apollo® Hericium Erinaceus Super-Quality Healthy Oral Liquid
3. Label in foreign language
4. Wo Hong Tong Double Action Bai Fung Pills
5. Thousand Oil 45g

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration 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 its quality, safety and efficacy. 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.

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]. 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.2020-1612

FDA Advisory No. 2020-1611-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. Ejiao 10g
2. OTC Jing Wan Hong Ruan Gao
3. WT® (Label in foreign language)
4. Heart Tonic Pills High Concentrated Health Product Comprises Precious Chinese Herbs
5. OTC Weitai “999” Granule Sanjiu Weitai Keli

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

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

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]. 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.2020-1611-A

FDA Advisory No. 2020-1611|| 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. Ejiao 10g
2. OTC Jing Wan Hong Ruan Gao
3. WT® (Label in foreign language)
4. Heart Tonic Pills High Concentrated Health Product Comprises Precious Chinese Herbs
5. OTC Weitai “999” Granule (as reflected in the secondary packaging)
Sanjiu Weitai Keli (as reflected in the package insert)

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the Agency and 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.

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]. 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.2020-1611

FDA Advisory No. 2020-1610-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 Paracetamol, Caffeine and Aspirin Powder
2. OTC Yunnan Baiyao Qiwuji
3. Label in foreign language
4. OTC Baojikoufuye
5. Natural Canvisol KSADTON Natural Herbals Formula

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

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

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]. 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.2020-1610-A

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