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

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

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

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

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

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

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

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

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No. 2019-385