Simple Diagnostics is recalling three lots of Pharmacist Choice Alcohol Prep Pads used to prepare patients’ skin prior to injection and for first aid treatment because their sterility and quality cannot be guaranteed. Use of compromised Alcohol Prep Pads could cause infections.
The prep pads were manufactured by Foshan Flying Medical Products Co. Ltd., based in China, and were supplied to distributors and pharmacies. They are used by health care professionals as well as patients, and are often used to decrease germs in minor cuts, scrapes and burns.
Affected lots of the Pharmacist Choice Alcohol Prep Pads are marked with the following codes: SD2070421201 (Exp. 12/2019), SD2070420925 (Exp. 09/2019) SD2070420601 (Exp. 12/2019), and have the UPC # 898302001050, and NDC # 98302-0001-05. The lots were distributed between Oct. 18, 2016 and July 19, 2017.
Simple Diagnostics is notifying its distributors and customers by letter and arranging for the return of all recalled products. Anyone who has affected Pharmacist Choice Alcohol Prep Pads should stop using them and return them to Simple Diagnostics.
On May 25, the Food and Drug Administration (FDA) placed all drug products made by Foshan on import alert to stop them from entering the U.S., but were concerned that the products were still being distributed within the country. As a safety measure, the FDA in September warned health care professionals and consumers not to use alcohol prep pads or benzalkonium chloride antiseptic towelettes manufactured by Foshan Flying Medical Products because of sterility concerns. Distributors of the product included Simple Diagnostics, as well as Total Resources International.
To date, Simple Diagnostics has not received any adverse events related to this recall. But anyone who has experienced any infections or other adverse reactions after using affected alcohol prep pads should file a report with the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
FDA Recall Notice