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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 health care settings, and remain a standard of care to prevent illness and the spread of infection,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “The FDA recommends that health care personnel continue to use these products consistent with infection control guidelines while additional data are gathered.” Health care antiseptics are primarily used by health care professionals in hospitals, clinics, doctors’ offices, outpatient settings and nursing ho ... Read more

Related support groups: Betadine, Betadine Douche, Betadine Mouthwash/Gargle, Summers Eve, Povidine, Lugols Solution, Lugols Strong Iodine, BD Butterfly Alcohol Pad, Iodine Mild, Betadine Surgical Scrub, Butterfly Alcohol Pad, Isopropyl Alcohol, Minidyne, Efodine, Topical Disinfection, Betadine Shampoo, Polydine, Antisept, Iodex, Betadine Surgi-Prep Brush

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 Iodine Prep solution that had previously been recalled by H & P Industries, Inc. The manufacturer did not conduct any microbial testing and the products did not meet proper finished specifications. These products may cause serious adverse health consequences, including death. See the Recall Notice for a listing of affected brand names and lot numbers.   [Posted 08/27/2011] ISSUE: H & P Industries and FDA notified health professionals and the public of a recall of all lots (lots beginning with 8 ... Read more

Related support groups: Betadine, Betadine Douche, Betadine Mouthwash/Gargle, Summers Eve, Povidine, Skin Disinfection, Preoperative, Povidex, Clinidine, Hospital Antiseptic, Betadine Shampoo, Minidyne, Betadine Surgi-Prep Brush, Antisept, Polydine, Betagen, Betadine Aerosol Spray, Povidex Peri, Efodine, Iodex, Betadine Skin Cleanser

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 First Aid Kits should immediately dispose of the Triad Povidone Iodine Prep Pads included in the First Aid Kits.   [Posted 03/18/2011] ISSUE: H&P industries, Inc., a manufacturer of over-the-counter products, initiated a voluntary product recall of ALL LOTS of Povidone Prep Pads manufactured by H&P Industries, Inc. but which are private labeled for many accounts. Analytical testing showed the presence of Elizabethkingia meningoseptica. Use of contaminated Povidone Prep Pads could lead to l ... Read more

Related support groups: Betadine, Betadine Douche, Betadine Mouthwash/Gargle, Summers Eve, Povidine, Povidex, Clinidine, Hospital Antiseptic, Betadine Shampoo, Minidyne, Betadine Surgi-Prep Brush, Antisept, Polydine, Betagen, Betadine Aerosol Spray, Povidex Peri, Efodine, Iodex, Betadine Skin Cleanser, Aerodine

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 for testing of incoming components, and without having procedures designed and established to prevent objectionable microorganisms in these drug products. Patients undergoing medical and surgical procedures, including those who are immunocompromised, have a high risk of infection from antiseptic surgical preparations that have been prepared, packaged, or held under insanitary conditions. This recall has been initiated at the request of FDA. BACKGROUND: Povidone Iodine Swabsticks, Povidone Iodine ... Read more

Related support groups: Betadine, Betadine Douche, Betadine Mouthwash/Gargle, Summers Eve, Povidine, Povidex, Clinidine, Hospital Antiseptic, Betadine Shampoo, Minidyne, Betadine Surgi-Prep Brush, Antisept, Polydine, Betagen, Betadine Aerosol Spray, Povidex Peri, Efodine, Iodex, Betadine Skin Cleanser, Aerodine

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