The Food and Drug Administration (FDA) is warning health care professionals and patients not to use alcohol pads or benzalkonium chloride antiseptic towelettes made by Foshan Flying Medical Products Co. Ltd., from China, because there are quality issues with the products including some that put the sterility of the products into question. These products were distributed by Total Resources International located in Walnut, California, and Simple Diagnostics Inc., located in Willston Park, New York.
On May 25, the FDA placed all drug products made by Foshan on import alert to stop them from entering the U.S. But the FDA is concerned that these products may still be distributed in the U.S. The FDA sent Foshan a warning letter on Aug. 1, for violations of good manufacturing practices.
Affected products distributed by Total Resources are listed as Alcohol Prep Pad, single count, with the NDC 54429-0101-1 and Antiseptic Towelettes, Benzalkonium Chloride/First Aid Antiseptic, single count. Affected products distributed by Simple Diagnostics are listed as Alcohol Prep Pads, 100 individual pads per package with the NDC 98302-0001-05 and Alcohol Pad, 70% Isopropyl Alcohol, Sterile. The FDA said additional products may be on the market.
Alcohol pads and antiseptic towelettes are used to prepare skin prior to injection and in first aid to decrease germs in minor cuts, scrapes and burns. Because of the quality concerns and sterility issues, use of these products could cause infections. To date, there have been no adverse events related to these products.
The FDA is urging patients, health care facilities and pharmacists with these products to stop using them immediately and to contact a doctor if they experience any adverse reactions. Any adverse events should also be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Safety Communication