[9/01/2017] 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.
Products distributed by Total Resources:
- Alcohol Prep Pad, single count, NDC 54429-0101-1
- Antiseptic Towelettes, Benzalkonium Chloride / First Aid Antiseptic, single count
Products distributed by Simple Diagnostics:
- Alcohol Prep Pads, 100 individual pads per package, NDC 98302-0001-05
- Alcohol Pad, 70% Isopropyl Alcohol, Sterile
Alcohol pads and antiseptic towelettes are used by health care professionals and patients for preparation of the skin prior to injection, as well as in first aid to decrease germs in minor cuts, scrapes and burns. The use of these alcohol pads and antiseptic towelettes could cause infections.
Patients, health care facilities and pharmacies that have alcohol pads and antiseptic towelettes labeled by Total Resource or Simple Diagnostics should immediately stop using them and discard the products. Patients should contact a doctor if they experienced any adverse reactions after using these products.
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.
To date, FDA has not received any adverse event reports related to the use of these alcohol pads or antiseptic towelettes. FDA asks health care professionals and consumers to report any adverse reactions to the FDA’s MedWatch program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm
- Download and complete the form, then submit it via fax at 1-800-FDA-0178
FDA is aware of the following products. However, there may be additional products on the market.