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ISSUE: Simple Diagnostics is voluntarily recalling three lots of Pharmacist Choice Alcohol Prep Pads (UPC # 898302001050, NDC # 98302-0001-05), which were manufactured by Foshan Flying Medical Products Co. Ltd., located in China, due to the lack of sterility assurance and other quality issues. The affected lots are:
SD2070421201 (Exp. 12/2019)
SD2070420925 (Exp. 09/2019)
SD2070420601 (Exp. 12/2019)
The affected lots were distributed between 10/18/2016 and 07/19/2017.
The use of impacted Alcohol Prep Pads could result in adverse events such as infections.
BACKGROUND: Pharmacist Choice Alcohol Preps are supplied to distributors and pharmacies. Pharmacist Choice Alcohol Preps 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.
RECOMMENDATION: Simple Diagnostics is notifying its distributors and customers by issuing a “Dear Customer” letter and arranging for the return of all recalled products. Healthcare providers t...