domingo, 3 de septiembre de 2017

Drug Safety and Availability > FDA alerts health care professionals and patients not to use alcohol pads or benzalkonium chloride antiseptic towelettes manufactured by Foshan Flying Medical Products

Drug Safety and Availability > FDA alerts health care professionals and patients not to use alcohol pads or benzalkonium chloride antiseptic towelettes manufactured by Foshan Flying Medical Products

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The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.


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.
For more information, please visit: Foshan Flying Medical Products Alert.

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