Medication Monitor

Generic Name (Trade Name—Company)
August 29, 2011

Povidone iodine products

(Various trade names—H&P Industries)
Contamination concerns prompt recall

FDA announced that H&P Industries, a manufacturer of OTC drug products, has initiated a voluntary recall of all lots of Povidone Iodine Swabsticks, Povidone Iodine Prep Solutions, Povidone Iodine Scrub Solutions, and Povidone Iodine Prep Gel (all lots beginning with 8J-8M, 9A-9M, 0A-0M, 1A-1C). 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 recall was requested by FDA because the manufacturer did not have in place a system for microbial testing at the time of release, did not have a system for testing of incoming components, and did not have procedures designed and established to prevent objectionable microorganisms in these drug products. Extensive testing by H&P Industries did not find contamination in these products, and the manufacturer has received no reports of adverse events or contamination attributed to these products.

These products were distributed nationwide to consumers.