H&P industries, Inc., a manufacturer of over-the-counter drug products has initiated a voluntary recall of ALL LOTS (Lots beginning with8J-8M, 9A-9M, 0A-0M, 1A-1C) of Povidone Iodine Swabsticks, Povidone Iodine PrepSolutions, Povidone Iodine Scrub Solutions, and Povidone Iodine Prep Gelmanufactured by H&P Industries, Inc. This recall has been initiated at the request of FDA.
H & P Industries, Inc. manufactured these PovidoneIodine products without having in place a system for microbial testing at thetime of release, without having a system for testing of incoming components,and without having procedures designed and established to prevent objectionablemicroorganisms in these drug products. Although H&P Industries, Inc.'sinvestigation and extensive testing did no t find contamination, and theproducts met H&P Industries, Inc., finished goods specifications, H&PIndustries, Inc. is voluntarily recalling all Povidone Iodine Products due toand in accordance with the Consent Decree of Condemnation, Forfeiture, andPermanent Injunction entered in the Eastern District of Wisconsin (Civil No.2:11-cv-00319-AEG) on June 13, 2011.
Povidone Iodine Swabsticks, Povidone Iodine Prep Solutions,Povidone Iodine Scrub Solutions, and Povidone Iodine Prep Gel are labeled as anantiseptic for preparation of the skin prior to surgery, and are used toprevent infection in minor cuts, scrapes and burns. The Povidone Iodine Scrubsolutions are labeled also for use as a surgical hand scrub for health careprofessionals. Patients undergoing medical and surgical procedures, includingthose who are immunocompromised, have a high risk of infection from antisepticsurgical preparations that have been prepared, packaged, or held underinsanitary conditions whereby they may have been rendered injurious to health. H&PIndustries, Inc. has not ever received reports of adverse events or contaminationattributed to these Povidone Iodine products.
The Povidone Iodine products were distributed nationwide tohealthcare customers. The swabsticks are packaged in individual packets of 1 or3 swabs and the Prep Solution, Scrub Solution and Prep Gel are sold in bottles.