MedWatch - The FDA Safety Information and Adverse Event Reporting Program
Alcohol Pads or Benzalkonium Chloride Antiseptic Towelettes by Foshan Flying Medical Products: FDA Alert - Lack of Sterility Assurance and Other Quality Issues
AUDIENCE: Pharmacy, Health Professional, Patient ISSUE: The U.S. Food and Drug Administration is alerting health care professionals and patients not to use alcohol pads or benzalkonium chloride antiseptic towelettes made by Foshan Flying Medical Products Co. Ltd., located in China, due to the lack of sterility assurance and other quality issues. These products are distributed by Total Resources International, Walnut, California, and Simple Diagnostics Inc., Williston Park, New York. The use of these alcohol pads and antiseptic towelettes could cause infections. BACKGROUND: FDA initially contacted Foshan on May 25, 2017, regarding a recall, and had several follow-up meetings with the company. However, Foshan has not taken action to remove its alcohol pads or antiseptic towelettes from the market. FDA placed all drug products made by Foshan on import alert on May 23, 2107, to stop these products from entering the United States. However, FDA is concerned these products might still be in U.S. distribution. FDA also sent Foshan a warning letter on August 1, 2017, for violations of current good manufacturing practice regulations. RECOMMENDATION: Patients, health care facilities and pharmacies that have alcohol pads and antiseptic towelettes labeled by Total Resource or Simple Diagnostics should immediately stop using them and discard the products. Patients should contact a doctor if they experienced any adverse reactions after using these products.
Read the MedWatch safety alert, including link to the FDA alert, at https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm574576.htm You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com. This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
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