FDA Advisory No. 2020-176 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

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

  1. Crocodile Trademark For Asthma 30 Tablets
  2. Primary packaging : Ling Nam Ultra Balm 20ml Secondary packaging: Ultra Balm 20 ml
  3. SANJIN Watermelon Frost 3g
  4. Jinling Superior Yinchiao Tablet (Chiehtupien) 120 Tabs
  5. Buddha Brand Yee Tin Medical Oil 30 ml
  6. Tortoise Snake Itch Discharge Toxin Clearing Pills 48’s
  7. Oren Herb Sperm – Endengering Pills 150’s
  8. DK New Generation Menopause Pill 100’s
  9. Tasly Compound Danshen Dripping Pills 180 pellets
  10. Cold Analgesic Gel Counterpain Cool® 60 grams
  11. DANSN Gan Mao Tong Film-Coated Tablets 24’s
  12. Golden Throat Lozenge 24g
  13. BJ Boje® Enema 20cc x 2
  14. Golden Cane-Sugar Free Golden Throat Candy 12’s
  15. Sumgel Enema “Aid” 20cc x 10
  16. DK Tonifying Lung Capsule 30’S
  17. Green Balm Mosquito Brand
  18. Polar Bear Brand Essential Embrocation 18ml
  19. KULIN Brand Laryngitis Pills 30’s
  20. OTC Fenbid® Ibuprofen Sustained-released Capsules 20’s
  21. MD® Pain Fighter Unisex 6 Patches

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

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

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

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

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

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-176