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FDA Medwatch Alert: Pharmacist Choice Alcohol Prep Pads by Simple Diagnostics: Recall - Lack of Sterility Assurance and Other Quality Issues

Posted 7 Dec 2017 by Drugs.com

[Posted 12/05/2017] ISSUE: 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 affected lots are: SD2070421201 (Exp. 12/2019) SD2070420925 (Exp. 09/2019) ...

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 ...

How to Prevent Painful Swimmer's Ear

Posted 19 Jun 2016 by Drugs.com

SATURDAY, June 18, 2016 – Swimmer's ear – a common summertime problem among children – is easy to prevent, an expert says. "Swimmer's ear is a bacterial or fungal infection caused by water caught in the ear canal. The tell-tale signs are swelling of the ear canal and some drainage or discharge," said Dr. Nina Shapiro, director of pediatric otolaryngology at Mattel Children's Hospital of the ...

FDA Issues Proposed Rule to Address Data Gaps for Certain Active Ingredients in Health Care Antiseptics

Posted 30 Apr 2015 by Drugs.com

April 30, 2015 – The U.S. Food and Drug Administration today issued a proposed rule requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in health care antiseptics marketed under the over-the-counter drug monograph. “Health care antiseptics are an important component of infection control strategies in hospitals, clinics and other h ...

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, ...

Health Tip: Clean a Wound Carefully

Posted 25 Jan 2012 by Drugs.com

-- When you get a cut, scrape or minor puncture wound, careful cleaning can help prevent an infection. The American Academy of Family Physicians offers these suggestions for cleaning a minor wound: Run cool water over the wound, either by pouring from a cup or holding the area under running water. Using a soft washcloth and soap, gently clean the skin. Avoid applying soap directly in the wound. ...

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