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.
- Alcohol Prep Pad, single count, NDC 54429-0101-1
- Antiseptic Towelettes, Benzalkonium Chloride / First Aid Antiseptic, single count
- Alcohol Prep Pads, 100 individual pads per package, NDC 98302-0001-05
- Alcohol Pad, 70% Isopropyl Alcohol, Sterile
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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