The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:
- OTC YUNNAN BAIYAO QIWUJI
- CISEN GENTAMICIN SULFATE INJECTION
- PANTOPRAZOLE SODIUM ENTERIC-COATED TABLETS
- YATAI® AZITHROMYCIN FOR INJECTION
- ERYTHROMYCIN ENTERIC-COATED TABLETS
- OTC NAOXINSHU KOUFUYE
- OTC YESUANPIAN [as reflected in the primary and secondary packaging]
FOLIC ACID TABLET [as reflected in the package insert]
- OTC CETIRIZINE HYDROCHLORIDE TABLETS
- KANGMEI MCKIN VITAMIN C TABLET (WITH LEMON)
- KANGMEI MCKIN VITAMIN C TABLET (WITH BLUEBERRIES)
- BIOHEK BAIHEKANG BRAND VITAMIN C LOZENGE
- HUAYI® DEXAMETHASONE SODIUM PHOSPHATE INJECTION
- DONGYAO ETHAMSYLATE INJECTION
- CEFOPERAZONE SODIUM AND SULBACTAM SODIUM FOR INJECTION
- SPECTINOMYCIN HYDROCHLORIDE FOR INJECTION
[as reflected in the primary and secondary packaging-Vial]
CISEN BENZYL ALCOHOL INJECTION
[as reflected in the package insert-Ampoule]
- OTC QINGXUAN PIAN
- YATAI® ACICLOVIR FOR INJECTION
- OTC ZHIKEPIPA KELI
- XINYAXILE DANSHENZHUSHEYE
- ZHEN ZHU MING MU YAN BU HU LI YE
- 1 YI LHENG ZHUIFENGSHU JINGHUO XUEPIAN
- TONGREN DAHUOLUO WAN
- YANGXUE SHENGFA JIAONANG
- CNWM YOUGUI WAN
- CONBA JIXUEGANSHUANG RUANGAO
- YUSHANPAI LONGXUEJIE JIAONANG
- ORIGINAL® PEPPERMINT AQUA
- PIFUBING XUEDU WAN
- ZUYAXI FEBUXOSTAT TABLETS
- OTC CONCENTRATED TINIDAZOLE GARGLES
- VALACICLOVIR HYDROCHLORIDE TABLETS
- ACYCLOVIR EYE DROPS
- OTC NAPHAZOLINE HYDROCHLORIDE NASAL DROPS
- SINE® DICLOFENAC SODIUM SUSTAINED-RELEASE TABLETS
- XIAONUO NORFLOXACIN CAPSULES
- COMPOUND KETOCONAZOLE LOTION
- TINIDAZOLE AND SODIUM CHLORIDE INJECTION
- OTC NIN JIOM PEI PA KOA
- ROXITHROMYCIN TABLETS
- CEFUROXIME AXETIL TABLETS
- YATAI® PHENOXYMETHYLPENICILLIN POTASSIUM TABLETS
- YATAI®AMOXICILLIN CLAVULANATE POTASSIUM DISPERSIBLE TABLETS
- HALCINONIDE SOLUTION
- VITAMIN B6 INJECTION
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. 2019-386