The US FDA is concerned over a lack of sterility assurance and other quality issues with specific products made by the Chinese company from Foshan City, Guangdong Provence
The US Food and Drug Administration is alerting healthcare 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.
The 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 US. However, FDA is concerned these products might still be in US distribution. FDA also sent Foshan a warning letter on August 1, 2017, for violations of current good manufacturing practice regulations.
Patients, healthcare 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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.