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  4. Simple Diagnostics, Inc. Issues Voluntary Nationwide Recall of Foshan Flying Medical Alcohol Pads Due to the Lack of Sterility Assurance and Other Quality Issues
  1. Recalls, Market Withdrawals, & Safety Alerts

COMPANY ANNOUNCEMENT

Simple Diagnostics, Inc. Issues Voluntary Nationwide Recall of Foshan Flying Medical Alcohol Pads Due to the Lack of Sterility Assurance and Other Quality Issues

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Recall Reason Description
Due to Lack of Sterility Assurance
Company Name:
Simple Diagnostics
Brand Name:
Brand Name(s)
Pharmacist Choice
Product Description:
Product Description
Alcohol Prep Pads

Company Announcement

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.

Consumers

Simple Diagnostics
1-877-342-2385