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Alcohol Prep Pads Recall; Lack of Sterility Assurance; Quality Issues


On December 5, 2017, Simple Diagnostics recalled three lots of Pharmacist Choice Alcohol Prep Pads due to the lack of sterility assurance and other quality issues. The recalled lots were manufactured by Foshan Flying Medical Products Co. Ltd., located in China.

 

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.

 

The use of the recalled Alcohol Prep Pads could result in adverse events such as infections.

 

The recalled lots were distributed between October 18, 2016, and July 19, 2017. The affected lots are SD2070421201 (Exp. 12/2019), SD2070420925 (Exp. 09/2019), and SD2070420601 (Exp. 12/2019). The recalled lots have the UPC number 898302001050 and the NDC number 98302-0001-05.

 

See the FDA Safety Alert

 

See the Recall

 

See also Medical Law Perspectives Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication

 

See also Medical Law Perspectives Report: Unclean, Unsterile, Unsafe: Risks of Injury from Unsterilized Medical Equipment

 

 

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