By Christine Fabro
The Food and Drug Administration (FDA) warned the public against the purchase and use of unregistered Chinese medicines in an advisory dated May 4 and posted on their website on June 25.
In FDA Advisory No. 2021-0918-A, the FDA requested all local government units and law enforcement agencies to ensure that these products are not sold or made available in their localities or areas of jurisdiction:
OTC An Ka Huang Min Jiaonang, Zhongsheng Pharma Rifampicin Capsules, Rupixia Pian, BICON Fe De An® Dexamethasone Sodium Phosphate Injection, and FORTUNE Non-Drowsy Coltalin-ND® Maximum Strength Cold & Sinus Formula.
These are claimed to be medicines for fever, colds, and other viral diseases.
According to FDA post-marketing surveillance (PMS) activities, it was verified that these medicines have not gone through the FDA registration process and have not been issued with proper authorization through a certificate of product registration.
As such, the FDA said they cannot guarantee the “quality, safety, and efficacy” of these products and that the “consumption of such violative products may pose potential danger or injury to health.”
The FDA warned all concerned establishments and entities to not distribute the violative drug products without proper authorization. – jlo
