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FDA Medwatch Alert: Alcohol Pads or Benzalkonium Chloride Antiseptic Towelettes by Foshan Flying Medical Products: FDA Alert - Lack of Sterility Assurance and Other Quality Issues

Posted 7 Sep 2017 by Drugs.com

[Posted 09/01/2017] 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, ...

FDA Asks How Safe Is That Hand Sanitizer?

Posted 29 Jun 2016 by Drugs.com

WEDNESDAY, June 29, 2016 – Millions of Americans use hand sanitizers every day, believing they safely kill bacteria. Now, the U.S. Food and Drug Administration wants to find out if that's really true. The agency Wednesday requested makers of antibacterial hand sanitizers and related products to provide data showing the products' active ingredients actually reduce bacteria and are harmless over ...

FDA Seeks to Improve Safety of Antiseptic Swabs

Posted 14 Nov 2013 by Drugs.com

THURSDAY, Nov. 14 – Manufacturers of antiseptic swabs and solutions are being asked to make voluntary labeling and packaging changes, the U.S. Food and Drug Administration said Thursday. The goal is to improve the products' safety when applied to the skin before surgery or injections. Reports of infections linked to the over-the-counter antiseptics are infrequent but continuing, the agency said ...

FDA Medwatch Alert: Over-the-Counter Topical Antiseptic Products: Drug Safety Communication - FDA Requests Label Changes and Single-Use Packaging to Decrease Risk of Infection

Posted 13 Nov 2013 by Drugs.com

ISSUE: The U.S. Food and Drug Administration (FDA) is requesting label and packaging changes to enhance the safe use of certain over-the-counter (OTC) topical antiseptic products. This request is the result of our ongoing evaluation of infrequent but continuing reports of infections resulting from antiseptic products labeled for preoperative or preinjection skin preparation.  When used properly, ...

FDA Medwatch Alert: Benzalkonium Chloride Antiseptic Wipes by Dukal: Recall - Potential Microbial Contamination

Posted 1 Aug 2012 by Drugs.com

ISSUE: Dukal Corporation announced a U.S. voluntary nationwide recall of selected lots of benzalkonium chloride swabs and antiseptic wipes manufactured for Dukal by Jianerkang Medical Dressing Co. This recall is being initiated due to concerns about potential microbial contamination with Burkholderia cepacia. Use of contaminated wipes could lead to infections, some of which pose health risks in ...

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