Alcohol Prep Pad and Antiseptic Towelette Sterility Warning Issued By FDA
Some antiseptic and alcohol towelettes commonly used to clean cuts and skin before injections may not be sterile, creating a risk that users may develop an infection, according to federal health officials.
On September 1, the FDA issued a warning on alcohol pads and antiseptic towelettes manufactured by Foshan Flying Medical Products Co. Ltd.; calling for all consumers and medical professional not to use the products.
The alcohol and antiseptic pads and towelettes are commonly stocked in doctors’ offices, hospitals, and first aid kits in many settings. The products are used on the skin to sterilize the site before an injection or blood draw, and to clean minor cuts, scrapes and burns to decrease the risk of infection. However, the FDA warns that the affected products were not manufactured under sterile conditions and pose a threat of infection.
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The FDA initially contacted Foshan on May 25, 2017 over quality control problems. After repeated follow-up meetings, the FDA claims Foshan refused to issue a recall.
All products made by Foshan were placed on an import alert on May 23, 2017, to stop the alcohol prep pads and antiseptic towelettes from entering the country. The agency also issued a warning letter to Foshon on August 1, regarding violations of “current good manufacturing practice regulations.”
Despite the steps taken, the agency is concerned the products may still be in distribution in the United States. To date, no adverse events have been reported.
The products include alcohol pads and benzalkonium chloride antiseptic towelettes manufactured by Foshan and distributed by Total Resources International, in Walnut, California, and Simple Diagnostics Inc., in Williston Park, New York.
The Total Resources products include Alcohol Prep Pads, single count, labeled with NDC 54429-0101-1, and Antiseptic Towelettes, Benzalkonium Chloride / First Aid Antiseptic, single count. The Simple Diagnostics products affected by the warning include Alcohol Prep Pads, 100 individual pads per package, NDC 98302-0001-05; and Alcohol Pad, 70% Isopropyl Alcohol, Sterile.
The FDA warns consumers and healthcare providers should immediately stop using the pads and towelettes, discard the products, and contact a doctor and the FDA MedWatch Adverse Event Reporting Program if any adverse reactions are experienced after use.
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