FDA ALERT: H&P Industries Issues Voluntary Recall of Various Povidone Iodine Drug Products

August 30, 2011

The Food and Drug Administration (FDA) has issued a Safety Alert about the voluntary recall by H&P Industries, salve Inc. of all lots of Povidone Iodine swabsticks, prep solutions, scrub solutions, and prep gel manufactured by the company.

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. H&P Industries, Inc. has not ever received reports of adverse events or contamination attributed to these Povidone Iodine products.

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.

The alert was released on August 24, 2011.  According to the recall, H&P Industries, Inc. manufactured the 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.”

An investigation by H&P did not find contamination, however the company is voluntarily recalling all of the Povidone Iodine products due to and in accordance with a 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.

 

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