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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 Medwatch Alert: H & P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel: Recall - Inadequate Microbial Testing

Posted 26 Sep 2012 by Drugs.com

Multiple brands affected - listed below [UPDATED 09/18/2012] Custom Medical Specialties, Inc., Custom HSG Tray, Hysteroscopic Sterilization Pack, Custom Vein Tray, Custom Amnio Tray, Fox Chase Specials Pack, Abington Radiology Drainage Pack, Custom CT Biopsy Tray, HSG Tray, Custom Myelogram Tray, and Hysteroscopy Sterile Procedure Kit. Class 1 Recall. The custom surgical kits contain Povidone ...

FDA Medwatch Alert: H & P Industries Povidone Iodine Prep Pads: Recall - Potential Microbial Contamination

Posted 16 Sep 2011 by Drugs.com

Including products under brand names Cardinal Health, Medical Specialties, VHA, Triad, Triad Plus, North Safety, Total Resources, Atwater Carey, Lee Medical International [UPDATED 09/16/2011] Lee Medical International Inc., Custom Dialysis Trays/Kits recalled. See the Recall Notice for a listing of affected brand names and lot numbers. [UPDATED 05/03/2011] Consumers using one of the affected ...

FDA Medwatch Alert: H & P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel: Recall - Inadequate Microbial Testing

Posted 28 Aug 2011 by Drugs.com

ISSUE: H & P Industries and FDA notified health professionals and the public of a recall of all lots (lots beginning with 8J-8M, 9A-9M, 0A-0M, 1A-1C) of Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel. H & P Industries, Inc. manufactured these Povidone Iodine products without having in place a system for microbial testing at the time of release, without having a system ...

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