H&P Industries, Inc., at the request of the U.S. Food and Drug Administration (FDA) has issued a voluntary recall of all lots of Povidone Iodine Swabsticks, Povidone Iodine Prep Solutions, Povidone Iodine Scrub Solutions and Povidone Iodine Prep Gel manufactured by H&P Industries, Inc. The manufacturer produced 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.

This recall involves all lots beginning with 8J-8M, 9A-9M, 0A-0M, 1A-1C.

There have been no reports or evidence of contamination after testing by H&P Industries, but the manufacturer is recalling the products because they do not meet proper finished goods specifications. The recall is 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 for preparation of the skin prior to surgery, and are used to prevent infection in minor cuts, scrapes and burns. The Povidone Iodine Scrub solutions are labeled also for use as a surgical hand scrub for health care professionals. 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 whereby they may have been rendered injurious to health.

The Povidone Iodine products were distributed nationwide to healthcare customers. The swabsticks are packaged in individual packets of 1 or 3 swabs and the Prep Solution, Scrub Solution and Prep Gel are sold in bottles.

Specific customers distributing the product and selling it at the wholesale and hospital level are being notified by e-mail with instructions on how to return the product. Consumers that have any of these types of products in their possession should not use the product and should return it to the place it was purchased.

Consumers with questions can call H&P Industries, Inc. at 262-538-2907 Monday through Friday between the hours of 8:30 A.M. and 4:00 P.M. Central Time.

Customers who directly purchased product from H&P should not return the product on their own. H&P is advising these customers to contact the manufacturer at recall.coordinator@handpindustries.com to make return arrangements.