Alcohol Pads or Benzalkonium Chloride Antiseptic Towelettes by Foshan Flying Medical Products: FDA Alert - Lack of Sterility Assurance and Other Quality Issues

From Drugs.com - August 31, 2017

Alcohol Pads or Benzalkonium Chloride Antiseptic Towelettes by Foshan Flying Medical Products: FDA Alert -Lack of Sterility Assurance and Other Quality Issues

Audience: Pharmacy, Health Professional, Patient

[Posted 09/01/2017]

ISSUE: The U.S. Food and Drug Administration is alerting health care professionals and patients not to use alcohol pads or benzalkonium chloride antiseptic towelettes made by Foshan Flying Medical Products Co. Ltd., located in China, due to the lack of sterility assurance and other quality issues. These products are distributed by Total Resources International, Walnut, California, and Simple Diagnostics Inc., Williston Park, New York. The use of these alcohol pads and antiseptic towelettes could cause infections.

BACKGROUND: FDA initially contacted Foshan on May 25, 2017, regarding a recall, and had several follow-up meetings with the company. However, Foshan has not taken action to remove its alcohol pads or antiseptic towelettes from the market.

FDA placed all drug products made by Foshan on import alert on May 23, 2107, to stop these products from entering the United States. However, FDA is concerned these products might still be in U.S. distribution. FDA also sent Foshan a warning letter on August 1, 2017, for violations of current good manufacturing practice regulations.

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