H&P industries, Inc., which makes over-the-counter (OTC) drug products, has initiated a recall of all lots of its Povidone Iodine Swabsticks, Povidone Iodine Prep Solutions, Povidone Iodine Scrub Solutions, and Povidone Iodine Prep Gel. This recall has been initiated at the request of U.S. Food and Drug Administration (FDA) and involves lots beginning with 8J-8M, 9A-9M, 0A-0M, and 1A-1C.
H & P Industries, Inc. manufactured these Povidone Iodine products without a system in place for microbial testing. There was also no system in place for testing of incoming components and there were no procedures in place to prevent objectionable microorganisms from entering and contaminating these drug products.
Although H&P Industries, Inc.’s says its investigation and extensive testing did not find contamination and the products met H&P Industries, Inc., finished goods specifications, H&P Industries, Inc. is recalling all of its Povidone Iodine products due to, and in accordance with, the Consent Decree of Condemnation, Forfeiture, and Permanent 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 an antiseptic skin preparation before surgery and are used to prevent infection in minor cuts, scrapes, and burn; Povidone Iodine Scrub solutions are labeled as a surgical hand scrub for health care professionals.
Patients undergoing medical and surgical procedures, especially those who are immunocompromised, have a high risk of infection from antiseptic surgical preparations that have been prepared, packaged, or held under insanitary conditions and that render the product injurious to health.
The recalled Povidone Iodine products were distributed nationwide to healthcare customers. Swabsticks are packaged in individual packets of 1 or 3 swabs; Prep Solution, Scrub Solution, and Prep Gel are sold in bottles. All of the products were distributed in the United States.
Those customers distributing the product and selling it at the wholesale and hospital level are being notified by email and being provided with instructions on how to return the product. Consumers in possession of these defective products are advised not to use the products and to return the recalled products to the place of purchase. H&P Industries, Inc. can be reached at 1.262.538.2907, from Monday through Friday between 8:30 a.m. and 4:00 p.m., Central Time (CT). Those customers who purchased any of these products directly from H&P are advised against making a direct return and should email H&P Industries, Inc. at recall.coordinator@handpindustries.com to make all return arrangements. Returns will be processed once recall acknowledgements and/or a notice of destruction are received.
U.S. Marshalls recently seized $6 million worth of medical products from H&P Industries Inc., which does business as Triad Group, at the behest of the FDA. The raid was prompted by the failure of H&P Industries to comply with the FDA’s current good manufacturing practice (cGMP) regulations. Over the past few months, Triad Group has issued several massive recalls of tainted alcohol prep pads, alcohol swabs, alcohol swabsticks, and other products sold under various brand names and because of potential Bacillus cereus contamination. H&P Industries also issued a Povidine Iodine Prep Pad recall because of concerns that they could be contaminated with Elizabethkingia meningoseptica, a type of bacteria associated with flesh eating bacteria disease, meningitis in newborn infants, and pneumonia in patients on ventilators.
Triad Group is the maker of recalled Triad alcohol wipes linked to a number of illnesses and deaths. Both Triad Group and H&P Industries Inc. have been accused of manufacturing and distributing alcohol products that were allegedly tainted with deadly bacteria and which led to serious reactions in already compromised patients. The dangerous bacteria—Bacillus cereus and Elizabethkingia meningoseptica—can lead to rare and deadly infections.
