The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:
- OTC Banlangen Keli Sachets 20’s
- OTC Ankahuangmin Jiaonang TS® – Paracetamol, Caffein, Atificial Cow-bezoar and Chlorphenamine Maleate Capsule [as reflected in the package insert]
- OTC Fuke Tiaojing Pian Tablet [as reflected in the package insert]
- [Label in foreign language]
- B.S® Yunsuan Anxiusuo Putaotang Zhusheye – Ambroxol Hydrochloride and Glucose Injection Vial 100 ml [as reflected in the package insert]
- HASEN® Yansuan Leinitiding Zhusheye – Ranitidine Hydrochloride Injection Ampoule 2ml:50mg
- Zhusheyong Lai’anpilin – Lysine Acetylsalicylate for Injection Vial 0.9g [as reflected in the package insert]
- OTC Fufang Banlangen Keli Sachet 10’s [as reflected in the package insert]
- Aomeilazuo Changrong Jiaonang – Omeprazole Enteric-coated Capsule 20mg [as reflected in the package insert]
- SHANGYUAN® Gaomengsuanjia
- Levofloxacin Lactate and Sodium Chloride Injection – Rusuan Zuoyangfushaxing Lvhuana Zhusheye 100 ml [as reflected in the package insert]
- Fu Bang Fu Kang Zuo Jiao Nang (Secondary packaging) Fluconazole Capsule 50 mg (Primary packaging)
- OTC Huoxiang Zhengqi Jiaonang Capsule
- Fu Bang Luo Hong Mei Su Jiao Nang 150 mg Capsule
- China Time-honored Brand Paishi Keli 20g Sachet[as reflected in the package insert]
- OTC shuangzuotai shuan – Metronidazole, Clotrimazole and Chlorhexidine Acetate Suppositories [as reflected in the package insert]
- Fufang Huangliansu Pian Tablet
- OTC Jianwei Xiaoshi Pian Tablet [as reflected in the package insert]
- OTC Newomen® Shier Wujibaifeng Wan Sachet 8’s
- OTC 999®Ganmaoling Keli Sachet 9’s
- Jiantong® Ganmaoqing Jiaonang Capsule
- Shineway Qingkailing Zhusheye Ampoule 10 ml [as reflected in the package insert]
- OTC Ke Te Ling Jiao Nang Capsule
- Danshenzhusheye Ampoule 10 ml
- OTC Yansuan Anxiusuo Pian – Ambroxol Hydrochloride Tablet [as reflected in the package insert]
- OTC CISEN® Hongmeisu Yangao – Erythromycin Eye Ointment [as reflected in the package insert]
- OTC [Label in foreign language]
- [Label in foreign language] 0.25g
- OTC [Label in foreign language]
- OTC Tian Ma Shou Wu Pian 0.5 g Tablet
- CSPC® [Label in foreign Language] 0.5g Vial
- JUCISHAN® Jigan Zhusheye – Inosine Injection Ampoule 2ml:100mg
- Progesterone Injection Ampoule 1ml:10 mg
FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration process of the Agency and 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.
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]. 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.2020-1262