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Friday, April 19, 2024

FDA rings alarm over China-made unregistered drugs

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The Food and Drug Administration (FDA) has warned the public against purchasing various unregistered Chinese drugs, such as probiotics, vitamins and supplements.

“All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device products until the Product Notification Certificates are issued, otherwise, regulatory actions and sanctions shall be strictly pursued,” the FDA said.

In a series of advisories, the FDA cited the following drugs which have not undergone the registration process and they do not have the corresponding authorization such as certificate of product registration.

-Topfond® Meheco H41020972 [Label in Foreign Language]

-Cenoca B-Complex Vitamins Tablet 0.55g

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-WY® Chloramphenicol Tablets 0.25g

-OTC Yansuan Saigengding Pian

-OTC Tongbianling Jiaonang

-Changweishi Connate Kang Probiotic Powder 30g

-BYS® Nimesulide Tablets 100 mg

-OTC Sanyi Clotrimazole Solution 8ml

-Zhiyangpianfang Zhongyaorugao 15g

-Metformin Hydrochloride Tablets 0.25g [Label in Foreign Language]

-OTC Vitamin E Soft Capsules

-A.T.P. Adenosine Disodium Triphosphate Tablets 20 mg

-Xinnaokang Jiaonang 0.25g [as reflected in the package insert]

-Shiduqingruangao

-Dabaidu Jiaonang

-OTC ZNW® Zhen Nan Wang Qingfei Yihuo Pian [as reflected in the package insert]

-BaiCaoZhiYangGao

-Ciprofloxacin Hydrochloride Tablets 0.25g [Label in Foreign Language]

-OTC Yangxue Anshen Pian [as reflected in the package insert]

-Compound Ferrous Sulfate and Folic Acid Tablets – Fufang Liusuanyatie Yesuan Pian 50mg [as reflected in the package insert]

-OTC Buzhong Yiqi Wan [as reflected in the package insert]

-Yatai® AMP Amoxicillin and Clavulanate Potassium Dispersible Tablets 156.25mg

-OTC Compound Beclometasone Dipropionate and Camphor Cream- Fufang

Beilü misong Zhangnao Rugao [as reflected in the package insert]

-Xiao Yan Zhi Ke Pian

-OTC JLS® Yuanhu Zhitong Pian

-Yuxingcao Eye Drops 8ml

-OTC Zhibai Dihuang Wan [as reflected in the package insert]

-OTC Zhike Ningsou Jiaonang

-OTC Folic Acid Tablets 0.4mg

-OTC Wuzi Yanzong Wan 9g

-XST KPC® Xuesaitong Pian

-Yangxue Shengfa Jiaonang

-Yansuan Fuguiliqin Jiaonang [as reflected in the secondary packaging]

-Flunarizine Hydrocloride Capsules [as reflected in the primary packaging]

-Yao Xi Tong Jiao Nang

The FDA said it cannot guarantee  for the quality and safety of the mask brand as the product has not gone through FDA’s evaluation process.

The FDA likewise  urged  the public to always check if a product has FDA certifications.

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