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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, Clinidine, Povidine, Hospital Antiseptic, Betadine Shampoo, Minidyne, Betadine Surgi-Prep Brush, Antisept, Polydine, Betagen, Betadine Aerosol Spray, Povidex Peri, Efodine, Betadine Mouthwash/Gargle
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, Clinidine, Povidine, Hospital Antiseptic, Betadine Shampoo, Minidyne, Betadine Surgi-Prep Brush, Antisept, Polydine, Betagen, Betadine Aerosol Spray, Povidex Peri, Efodine, Betadine Mouthwash/Gargle