The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:
- OTC XIAOYAO WAN
- POTASSIUM CHLORIDE SUSTAINED-RELEASE TABLETS [as reflected in the package insert]
DANGSHIPIAN [as reflected in the secondary packaging]
- CIMETIDINE INJECTION
- 999® C16H17N5O7S2 [as reflected in the primary packaging]
- XUEFU ZHUYU JIAONANG
- OTC TASLY® YANGXUE QINGNAO KELI
- OTC XIAOYAN TUIRE KELI
- OTC CONCENTRATED TINIDAZOLE GARGLES
- OTC FANGFENGTONGSHENGWAN
- QI LU AMIKACIN SULFATE INJECTION
- PROGESTERONE INJECTION
- VITAMIN C INJECTION
- CEFIXIME CAPSULES TOUBAOKEWO JIAONANG
- POTASSIUM CHLORIDE SUSTAINED-RELEASE TABLETS
- [LABEL IN FOREIGN LANGUAGE]
- MINGMU JILI WAN [as reflected in the package insert]
- CSPC YANGXUE SHENGFA JIAONANG
- XIAO YAN LI DAN PIAN
- LAITING PROGESTERONE SOFT CAPSULES
- SHENSHITONG KELI
- JINSUO GU JING WAN
- [LABEL IN FOREIGN LANGUAGE]
- OTC [LABEL IN FOREIGN LANGUAGE]
- LEVOFLOXACIN HYDROCHLORIDE AND SODIUM CHLORIDE INJECTION
- GLUCOSE INJECTION 5%
- LEVOFLOXACIN LACTATE AND SODIUM CHLORIDE INJECTION
- SODIUM CHLORIDE INJECTION 0.9%
- OTC PIEN TZE HUANG® HUO XIANG ZHENG QI SHUI
- HASEN INOSINE INJECTION
- FUFANG ANLIN BABITUO ZHUSHEYE
- HASEN CHLORPHENAMINE MALEATE INJECTION
- OTC BANLANGEN KELI
- OTC YINGIAO JIEDU KELI
- [LABEL IN FOREIGN LANGUAGE]
- OTC NIUHUANGSHANGQINGPIAN
- OTC 999®
- CARSICK TAPE
- YATAI® AMOXICILLIN CAPSULES
- YATAI® CEFTRIAXONE SODIUM FOR INJETION
- YATAI® CEFALEXIN CAPSULES
- OTC FUFANG LUOHANGUO ZHIKE KELI
- OTC DONG LING CAO PIAN
- OTC WU SHI CHA KE LI
- YU LONG MINIAONING CAPSULE
- OTC SHENGMAI YIN (DANG SHEN FANG)
- YABAO NIUHUANG JIEDU PIAN
- OTC HUMANWELL HEALTHCARE [as reflected in the secondary packaging]
- 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 [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)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