The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:
- OTC ORYZANOL TABLETS
- FEBUXOSTAT TABLETS
- AOLITAI ORNIDAZOLE CAPSULES
- Roxithromycin Capsules
- Omeprazole Sodium for INJECTION
- ADENOSINE DISODIUM TRIPHOSPHATE INJECTION
- JUCISHAN DEXAMETHASONE SODIUM PHOSPHATE INJECTION
- CEFTRIAXONE SODIUM FOR INJECTION
- ALLOPURINOL TABLETS
- CEFOTAXIME SODIUM FOR INJECTION
- ZX MOROXYDINE HYDROCHLORIDE TABLETS
- HUAN QIU FLUCONAZOLE AND SODIUM CHLORIDE INJECTION
- OTC FISHING PILL
- LUNDBECK FLUPENTIXOL AND MELITRACEN TABLETS (DEANXIT)
- ITRACONAZOLE HYDROCHLORIDE CAPSULES
- NEW LINDANE CREAM
- LUTEIN
- OTC PENTOXYVERINE CITRATE TABLETS
- OXYTETRACYCLINE TABLETS
- OTC FUFANGGANMAOLINGPIAN
- DIPYRIDAMOLE TABLETS
- OTC FUMASUAN TONGTIFEN PIAN
- OTC HOUKANG SAN
- OTC WEI C YINQIAO PIAN
- OTC [Label in Foreign Language]
- XCQM XUECHA QINGMU
- YABANG GROUP CARBAZOCHROME TABLETS
- ZN MENADIOL DIACETATE TABLETS
- BAOZHUPAI® [Label in Foreign Language]
- TRIVITAMINS B TABLETS [as reflected in the package insert]
- HUANQIU OFLOXACIN EAR DROPS [as reflected in the primary packaging and package insert]
- PR® RACEANISODAMINE TABLETS
- Jingkang Jiaonang
- 1 YI LHENG
- OTC [Label in Foreign Language]
- AZITHROMYCIN DISPERSIBLE TABLETS
- OTC NAPHAZOLINE HYDROCHLORIDE, CHLORPHENAMINE MALEATE AND VITAMIN B12 EYE DROPS EYE SIGHT
- KOUQIANGYAN PENWUJI
- OTC NYTH
- OTC ACUTE BRONCHITIS SYRUP
- OTC HUAHONG® XIAOZHONGZHITONGDING
- YUNNAN BAIYAO JIAONANG
- LOMEFLOXACIN HYDROCHLORIDE EYE DROPS
- OTC [Label in Foreign Language]
- OTC LORATADINE TABLETS [as reflected in the package insert]
- SPH DING LU BRAND® QINGGAN CHUANXINLIAN PIAN
- OTC 999® ZHENGTIAN WAN
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. 2019-387