Simple Diagnostics, Inc. Issues Voluntary Nationwide Recall of Foshan Flying Medical Alcohol Pads Due to the Lack of Sterility Assurance and Other Quality Issues
This recall has been completed and FDA has terminated this recall.
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- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Reason for Announcement:
Recall Reason DescriptionDue to Lack of Sterility Assurance
- Company Name:
- Simple Diagnostics
- Brand Name:
Brand Name(s)Pharmacist Choice
- Product Description:
Product DescriptionAlcohol Prep Pads
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 use of impacted Alcohol Prep Pads could result in adverse events such as infections. To date, Simple Diagnostics has not received any reports of adverse events associated with use of these Sterile alcohol prep pads, referenced below.
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 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
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 that have affected lots of Pharmacist Choice Alcohol Prep Pads that have been recalled should stop using the product and should return them to Simple Diagnostics.
Consumers with questions regarding this recall can contact Simple Diagnostics:
Medical Inquiries: Please contact Simple Diagnostics at 1-877-342-2385 Monday through Friday 9:00 AM - 6:00 PM Eastern
Drug Safety/Adverse Events: In the event of any adverse health effects associated with this product recall, contact Simple Diagnostics Drug Safety/Adverse at 1-877-342-2385 Monday through Friday 9:00 AM - 6:00 PM Eastern
Return Processing Questions: Please contact Simple Diagnostics at 1-877-342-2385 Monday through Friday 9:00 AM - 6:00 PM Eastern
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.