Month: September 2020

FDA Advisory No. 2020-1695 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products:

  1. AIZA’S SWEETS Pastillas de Ube Chewy Milk Candy, with Purple Yam, 20 Pieces, 134g
  2. RGIES Assorted Butterscotch Squares, 175gms
  3. NATY’S DELICACIES Pastillas de Ube
  4. INSTAYUM Mushroom Chips From Farm Fresh Whole Oyster Mushroom , Barbeque Flavor, 60g
  5. PADLA’S HOMEMADE PRODUCTS DE ORO’S BEST Original Pork Jerky, 50g

The FDA verified through post-marketing surveillance that the abovementioned food products are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Pursuant to the 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, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a 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, if available or the name of the product.

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

The Bureau of Customs is urged to restrain the entry of the unregistered imported products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered product, the online reporting facility, eReport can be accessed at  www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

 Attachment:->  FDA-Advisory-No.2020-1695

FDA Advisory No. 2020-1694 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplement:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products and food supplement:

  1. SEA & SALT Sweet Pusit, 50g
  2. EMY’S SWEETS AND PASTRIES Barquiron,132g
  3. BACOLOD’S MARGIES FILIPINO PASTRIES Broas, 180g
  4. JAY-JAY’S Peanut Butter 150g
  5. SWANSON Tongkat Ali, Sexual Health, Herbal Supplement, 400mg,120 Capsules

The FDA verified through post-marketing surveillance that the abovementioned food products and food supplement are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Pursuant to the 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, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products and food supplement have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products and food supplement until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a 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, if available or the name of the product.

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

The Bureau of Customs is urged to restrain the entry of the unregistered imported products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call (02)857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered product, the online reporting facility, eReport can be accessed at  www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

FDA-Advisory-No.2020-1694

/ In Food Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1694 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplement:

FDA Advisory No. 2020-1593 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplement:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products and food supplement:

  1. SUN REO Vanilla Sandwich Cookies,4 pairs, 33g (1.16oz)
  2. HML FOODS CORPORATION BICOL’S BEST Ready to Eat Bicol Express, Pork, 210g (17oz)
  3. NATURE PROSPER Dragon Fruit Coffee Sugar
  4. ADVANCE FORMULA L-Glutathione, White Charm, Dietary Supplement, 60 Capsules

The FDA verified through post-marketing surveillance that the abovementioned food products and food supplement are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Pursuant to the 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, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products and food supplement have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products and food supplements until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a product or food supplement 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, if available or the name of the product.

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

The Bureau of Customs is urged to restrain the entry of these unregistered imported products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call 8857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered product, the online reporting facility, eReport can be accessed at  www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

 Attachment:->  FDA-Advisory-No.2020_1693

/ In Food Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1593 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplement:

FDA Advisory No. 2020-1692 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplement:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND CONSUME the following unregistered food products and food supplement:

  1. SNS Grape King Ice Fruit Powder Drink, Grape Flavor,4g
  2. SNS MYLO’S Chocolate Powder 3 in 1, 4g
  3. CHAM Ring Toy Candy,24pcs
  4. MORINGAJOY Food Supplement, 100% Malunggay Leaves in Vegetable Capsules,350mg, 60 Capsules

The FDA verified through post-marketing surveillance that the abovementioned food products and food supplement are not registered and no corresponding Certificates of Product Registration (CPR) have been issued. Pursuant to the 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, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products and food supplement have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

All concerned establishments are warned not to distribute, advertise, or sell the said violative food products until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a 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, if available or the name of the product.

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

The Bureau of Customs is urged to restrain the entry of these unregistered imported products.

For more information and inquiries about this advisory, kindly contact the FDA Center for Food Regulation and Research through email [email protected] indicating on the subject the concerned Advisory, or call 8857-1900 local 8105 and 8112.

To report any sale or distribution of unregistered product, the online reporting facility, eReport can be accessed at  www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->  FDA-Advisory-No.2020-1692

 

/ In Food Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1692 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplement:

FDA Advisory No. 2020-1691 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device Products:

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the unregistered medical device products:

  1. NIPRO SYNTHETIC HOLLOW FIBER DIALYZER ELISIO 190HR
  2. NIPRO ELISIO – 17H SYNTHETIC HOLLOW FIBER POLYNEPHRON™\

The FDA verified through post-marketing surveillance that the above-mentioned medical device products are not registered and no corresponding Product Registration Certificates have been issued. Pursuant to the 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, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered medical device products have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.  

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products until the Product Registration Certificates are issued, otherwise, regulatory actions and sanctions shall be strictly pursued. Always check if a 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 in the form of either DVR-xxx or MDR-xxx.

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

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.                                                                                          

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA-Advisory-No.2020-1691

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

  1. H14020283 [Label in Foreign Language]1g
  2. Yabang Group H32020133 [Label in Foreign Language] 10mg
  3. Siluen® Litai Compound Amino Acid Injection (18AA) 5% 250mL
  4. Kelundayaochang® Glucose and Sodium Chloride Injection 250ml:12.5g:2.25g
  5. Kelundayaochang® Glucose And Sodium Chloride Injection 500ml:25g:4.5g

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.2020-1690-A

FDA Advisory No. 2020-1690 || 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. H14020283 [Label in Foreign Language] 1g
  2. Yabang Group H32020133 [Label in Foreign Language] 10mg
  3. Siluen® Litai Compound Amino Acid Injection (18AA) 5% 250mL
  4. Kelundayaochang® Glucose and Sodium Chloride Injection 250ml:12.5g:2.25g
  5. Kelundayaochang® Glucose And Sodium Chloride Injection 500ml:25g:4.5g

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.2020-1690

FDA Advisory No. 2020-1689-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. Yatai® Spironolactone Tablets 20mg
  2. OTC Cyproheptadine Hydrochloride Tablets
  3. Lifeng® Nifedipine Tabiets 10mg
  4. OTC H43020325 [Label in Foreign Language]
  5. OTC Xinwufeng H33021418 [Label in Foreign Language]

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.2020-1689-A

FDA Advisory No. 2020-1689 || 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. Yatai® Spironolactone Tablets 20mg
  2. OTC Cyproheptadine Hydrochloride Tablets
  3. Lifeng® Nifedipine Tabiets 10mg
  4. OTC H43020325 [Label in Foreign Language]
  5. OTC Xinwufeng H33021418 [Label in Foreign Language

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.2020-1689

 

 

 

FDA Advisory No. 2020-1688-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. Shilintong Pian
  2. Xinwufeng H33022029 [Label in Foreign Language]
  3. OTC H35021094 [Label in Foreign Language]
  4. Vitamin A and D Soft Capsules
  5. Captopril Tablets 25mg

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.2020-1688-A

ANNOUNCEMENT || Launching of FDA VERIFICATION PORTAL

The Food and Drug Administration,in its commitment to provide
stakeholders with streamlined and improved government services,
has developed the FDA Verification Portal System. This online
portal provides comprehensive lists of FDA Licensed
Establishments and Registered Products thus ensuring
consumers access to safe and quality commodities in the market.

The FDA wishes to inform th public that is now Accessible through the website link https://verification.fda.gov.ph.

 

Attachment:-> FDA Verification Portal System

FDA Advisory No. 2020-1688 || 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. Shilintong Pian
  2. Xinwufeng H33022029 [Label in Foreign Language]
  3. OTC H35021094 [Label in Foreign Language]
  4. Vitamin A and D Soft Capsules
  5. Captopril Tablets 25mg

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.2020-1688

FDA Advisory No. 2020-1687-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 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

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.2020-1687-A

 

FDA has released a total of 260 COVID – 19 Test Kits (89 – PCR based, 93 – Rapid Antibody, 58 – Immunoassay and 20 – Others)

As of 29 September 2020,  FDA has released a
total of 260 COVID – 19 Test Kits (89 – PCR based,
93 – Rapid Antibody , 58 – Immunoassay and 20 – Others).

Click the link below for details.

https://bit.ly/2Zd0CZ4

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. 2020-704-A || Lifting the Advisory on the Notified Product “CHICCO DENTIFRICIO TOOTHPASTE (MELA-APPLE BANANA)” under FDA Advisory No. 2020-704 “Public Health Warning Against the Purchase and Use of Unnotified Cosmetic CHICCO DENTIFRICIO TOOTHPASTE (MELA-APPLE BANANA)” Dated 16 April 2020

The Food and Drug Administration (FDA) informs the public that the Cosmetic product CHICCO DENTIFRICIO TOOTHPASTE (MELA-APPLE BANANA) with Notification No. 1000006556643 has been notified by the Market Authorization Holder, Europlay Distributor Company, Inc., in accordance with existing FDA rules and regulations.

Accordingly, the warning against the purchase and use of the subject product as mentioned in FDA Advisory No. 2020-704 and FDA Order No. 2020-445 is hereby lifted.

The public is advised to always check if a Cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the health product before purchasing. For more information or inquiries, please email us at [email protected], you may also call the Center for Cosmetics Regulation and Research at telephone number (02) 8857-1900 loc. 8113 or 8117.

To report the sale or distribution of any unnotified/unregistered health products, kindly email FDA via [email protected].

Furthermore, the issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->  FDA-Advisory-No.2020-704-A

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-704-A || Lifting the Advisory on the Notified Product “CHICCO DENTIFRICIO TOOTHPASTE (MELA-APPLE BANANA)” under FDA Advisory No. 2020-704 “Public Health Warning Against the Purchase and Use of Unnotified Cosmetic CHICCO DENTIFRICIO TOOTHPASTE (MELA-APPLE BANANA)” Dated 16 April 2020

FDA Advisory No. 2020-1104-A || Lifting the Advisory on the Notified Cosmetic Product “MANUKA HEALTHY HONEY 100% NATURAL LIP BALM” under FDA Advisory No. 2020-1104 “Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic Product MANUKA HEALTHY HONEY 100% NATURAL LIP BALM” Dated 16 June 2020

The Food and Drug Administration (FDA) informs the public that the Cosmetic product MANUKA HEALTHY HONEY 100% NATURAL LIP BALM with Notification No. 1000006589658  has been notified by the Market Authorization Holder, Bee Healthy Trading & Distribution Inc., in accordance with existing FDA rules and regulations.

Accordingly, the warning against the purchase and use of the subject product as mentioned in FDA Advisory No. 2020-1104 and FDA Order No. 2020-748 is hereby lifted.

The public is advised to always check if a Cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the health product before purchasing. For more information or inquiries, please email us at [email protected], you may also call the Center for Cosmetics Regulation and Research at telephone number (02) 8857-1900 loc. 8113 or 8107.

 To report the sale or distribution of any unnotified/unregistered health products, kindly email FDA via [email protected].

Furthermore, the issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:–>FDA Advisory No.2020-1104-A

/ In Cosmetic Advisories / By FDA Admin3 / Comments Off on FDA Advisory No. 2020-1104-A || Lifting the Advisory on the Notified Cosmetic Product “MANUKA HEALTHY HONEY 100% NATURAL LIP BALM” under FDA Advisory No. 2020-1104 “Public Health Warning Against the Purchase and Use of Unauthorized Cosmetic Product MANUKA HEALTHY HONEY 100% NATURAL LIP BALM” Dated 16 June 2020

ANNOUNCEMENT || RESCHEDULE OF ONLINE PUBLIC CONSULTATION ON THE DRAFT GUIDELINES FOR THE REGULATION OF VAPOR PRODUCTS AND HEATED TOBACCO PRODUCTS IN RELATION TO THE PROVISIONS UNDER RA 11346, RA 11467 AND EO 106

Due to unforeseen technical issues with the registration link wherein several stakeholders are unable to access and submit the online registration form, we would like to inform all concerned stakeholders that the Online Public Consultation on the Draft Guidelines for Vapor Products and Heated Tobacco Products originally scheduled on 29  September and 01 October 2020 are moved to 06 and 08 October 2020 respectively to provide all interested stakeholders ample time to register and attend the public consultation.

All stakeholders are invited to participate by registering through the links provided below:

Vapor Product Stakeholders:

https://bit.ly/3i8pK9E

Heated Tobacco Product Stakeholders:

https://bit.ly/3mWemkH

The FDA shall accommodate a maximum of one hundred (100) participants per session and shall be on a first-come, first-served basis. To ensure that all stakeholders are given equal opportunities to attend the public consultation, only one (1) representative per company/industry association shall be allowed to register. Deadline for registration is on 04 October 2020, 4:00PM.

Below is the scheduled program for the said dates:

06 October 2020
Vapor Product Draft Regulatory Guidelines
AM Session (Batch 1)
8:00-8:15 Opening Remarks
8:16-9:15 Policy Overview and Licensing Guidelines
9:16-9:30 Break + Q&A
9:31-10:30 Product Marketing Authorization Guidelines for Vapor Products
10:31-10:45 Break + Q&A
10:46-11:45 Policy Salient Points and Product Labelling Guidelines
11:46-12:00 Q&A and Closing
PM Session (Batch 2)
1:00-1:15 Opening Remarks
1:16-2:15 Policy Overview and Licensing Guidelines
2:16-2:30 Break + Q&A
2:31-3:30 Product Marketing Authorization Guidelines for Vapor Products
3:31-3:45 Break + Q&A
3:46-4:45 Policy Salient Points and Product Labelling Guidelines
4:46-5:00 Q&A and Closing
08 October 2020
Heated Tobacco Product Draft Regulatory Guidelines
8:00-8:15 Opening Remarks
8:16-9:15 Policy Overview and Licensing Guidelines
9:16-9:30 Break + Q&A
9:31-10:30 Product Marketing Authorization Guidelines for HTPs
10:31-10:45 Break + Q&A
10:46-11:45 Policy Salient Points and Product Labelling Guidelines
11:46-12:00 Q&A and Closing

For any concerns or inquiries, kindly contact CCRR at (02) 857-1900 local 8107 or 8113, or through email at [email protected].

For your information and guidance.

Procedures on the registration for the Public Consultation:

1. Please click the link provided below for the registration:
Vapor Products: https://bit.ly/3i8pK9E
Heated Tobacco https://bit.ly/3mWemkH
2. Be sure to fill out the required fields.
3. Make sure you click Submit.
4. Google Meet Link for the Public consultation will be sent to your registered email address.

/ In Cosmetic Announcements / By FDA Admin3 / Comments Off on ANNOUNCEMENT || RESCHEDULE OF ONLINE PUBLIC CONSULTATION ON THE DRAFT GUIDELINES FOR THE REGULATION OF VAPOR PRODUCTS AND HEATED TOBACCO PRODUCTS IN RELATION TO THE PROVISIONS UNDER RA 11346, RA 11467 AND EO 106

Administrative Order No. 2020-0044 || Adoption of the Collaborative Procedure for the Accelerated Registration of World of Health Organization (WHO) – Prequalified Pharmaceutical Products and Vaccines

Attachment:->  Administrative Order 2020-0044

/ In General Announcements / By FDA Admin3 / Comments Off on Administrative Order No. 2020-0044 || Adoption of the Collaborative Procedure for the Accelerated Registration of World of Health Organization (WHO) – Prequalified Pharmaceutical Products and Vaccines

FDA Advisory No. 2020-1757 || Public Health Warning Against the Purchase and Use of the following Non-Compliant Cosmetic Products:

The Food and Drug Administration (FDA) warns the public from purchasing and using the following non-compliant cosmetic products imported and distributed by the Market Authorization Holder (MAH), Healthy Innovation Distribution Inc.:

1. FRESH SKINLAB 98% TOMATO GLASS SKIN WATER DROP CREAM SPF 30
2. FRESH SKINLAB 98% TOMATO GLASS SKIN SUN GEL SPF 50 PA++++
3. SUNGLOW BY FRESH TINTED LIPSCREEN SPF 50 PA++++
4. FRESH SKINLAB 98% JEJU ALOE ICE UV SUN BLOCK FOR FACE & BODY SPF 50 PA++

According to Republic Act 3720 as amended, a cosmetic shall be deemed misbranded if its labeling is false or misleading in any particular. Furthermore, the IRR of Republic Act 9711 defines “misbranding” as giving unsubstantiated claims, misinformation or misleading information on the label or other information materials.

The aforementioned cosmetic products were found non-compliant with the existing standards due to failure to substantiate the claim Sun Protection Factor (SPF) 50. Also, the MAH, Healthy Innovation Distribution Inc., has made misrepresentation and false entries in the applications for product notification based on the Centers’ post evaluation activities and product information file (PIF) audit by declaring Coreholic Co., as the manufacturer which is inconsistent from the relevant documents submitted for notification, rendering the products unauthorized.

In light of the foregoing, the public is advised not to purchase the aforementioned misbranded products. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph.) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute misbranded cosmetic products.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

Attachment:-> FDA-Advisory-No.2020-1757

ANNOUNCEMENT || POSTER MAKING COMPETITION FOR 2020 NATIONAL CONSCIOUSNESS WEEK AGAINST COUNTERFEIT MEDICINES (NCWACM)

  1. BACKGROUND

By virtue of the Republic Act No. 8203 otherwise known as the “Special Law on Counterfeit Drugs” issued on the 19th of November 1996, this was established to:
1) protect and promote the right to health of the people and instill health consciousness among them as provided in Section 15 Article 11 of the constitution; and 2) to further declare the policy of the State that in order to safeguard the health of the people, the State shall provide for their protection against counterfeit drugs.

  1. ISSUE

On 15 June 2010, Presidential Proclamation No. 2082 was issued to declare the third week of November of every year as the “National Consciousness Week against Counterfeit Medicines”. As such, it’s directed for the: 1) planning, coordination, and implementation of comprehensive public awareness programs and activities on counterfeit medicines through a collaborative inter-agency and multi-sectoral effort at all levels, and 2) to particularly ensure widespread and expeditious public information about the proliferation and dangers of counterfeit medicines.

In this regard, the FDA through the Center for Drug Regulation and Research shall be spearheading the 2020 NCWACM with the theme, “Sa Gitna ng Pandemya, Magtulungan Laban sa Pekeng Medisina” through a virtual celebration, i.e., webinar. Also, it was decided that to engage the general public, an online poster making contest is recommended.

  1. FINDINGS/COMMENTS/ANALYSIS

In line with the abovementioned proposed poster making contest, the technical working group for the observance of the 2020 NCWACM proposes the following:

  1. The contest is open to all ages.
    1. The poster must illustrate, interpret, and emphasize the theme of the 2020 NCWACM.
    2. The poster must be in PNG format, 24 x 36 size, and with 4000 pixels by 6000 pixels.
    3. All entries must be submitted on 25 to 30 September 2020 only to [email protected] with the subject of e-mail as “2020 NCWACM Poster” and the body of the e-mail containing your full name, complete address, and contact details.
    4. There shall be a preliminary judging of all the submitted entries by the FDA through dissemination of the google form link through e-mail using the following criteria:
    • Relevance to the theme: 30%
    • Creativity & Presentation: 30%
    • Originality: 30%
    • Compliance with Requirements: 10%
    1. The finalists shall be uploaded to the FDA Facebook for online voting and online voting shall be open on 03 to 18 October 2020 only. A system shall be used for the awarding of points to each entry wherein one (1) point shall be given for every “Like” or thumbs-up and three (3) points for every “Share” of the entry;
    2. The top six (6) entries shall be awarded with the following prizes:
    • Grand Prize (One Entry) = 15,000
    • 1st Runner-Up = 12,000
    • 2nd Runner-Up = 10,000
    • 3rd Runner-Up = 8,000
    • 4th Runner Up = 5,000
    • 5th Runner Up = 3,000

     

    Furthermore, the top six (6) entries shall become the properties of Food and Drug Administration, which shall be used as Information, Education, and Communication (IEC) materials.

    1. RECOMMENDATION

     

    1. To launch an online poster making competition to allow the general public to showcase their creativity while participating in our cause amidst the pandemic.
    2. To allow the posting of the announcement for poster making contest in the FDA website and FDA Facebook.

 

Attachment:->  POSTER MAKING COMPETITION FOR 2020 NATIONAL CONSCIOUSNESS WEEK AGAINST COUNTERFEIT MEDICINES (NCWACM)

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