Healthcare providers should not use alcohol pads or benzalkonium chloride antiseptic towelettes made by China-based Foshan Flying Medical Products Co Ltd because of the lack of sterility assurance and other quality issues, the US Food and Drug Administration (FDA) has advised in a safety communication.
“The use of these alcohol pads and antiseptic towelettes could cause infections,” the agency said.
These products are distributed by Total Resources International of Walnut, California, and Simple Diagnostics Inc of Williston Park, New York.
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Products distributed by Total Resources
Products distributed by Simple Diagnostics
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Despite several meetings with the company, Foshan has yet to take action to remove its alcohol pads or antiseptic towelettes from the market, the FDA said.
On May 23, the FDA placed all drug products made by Foshan on import alert in an effort to stop these products from entering the United States. However, the FDA said it’s “concerned” these products might still be in US distribution.
The agency also sent the company a warning letter on August 1, for violations of current good manufacturing practice regulations.
The FDA advises healthcare facilities, pharmacies, and patients that have alcohol pads and antiseptic towelettes labeled by Total Resource or Simple Diagnostics to stop using them and discard the products.
Adverse events or side effects related to the use of these products should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
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