| TO: | DDS Regional Directors, STS Director, CTH Coordinators, Private Providers, CO Quality Management Personnel |
| FROM: | Daniel A. Micari, Director, Quality Management Services |
| DATE: | August 30,2011 |
| RE: | H and P Industries, Inc. Issues a Voluntary Recall of All Lots of Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel |
Product Recall Advisory
August 24, 2011 - H&P industries, Inc., a manufacturer of over-the-counter drug products has initiated a voluntary recall of ALL LOTS (Lots beginning with 8J-8M, 9A-9M, 0A-0M, 1A-1C)of Povidone Iodine Swabsticks, Povidone Iodine Prep Solutions, Povidone Iodine Scrub Solutions, and Povidone Iodine Prep Gel manufactured by H&P Industries, Inc. This recall has been initiated at the request of FDA.
H & P Industries, Inc. manufactured 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. Although H&P Industries, Inc.’s investigation and extensive testing did not find contamination, and the products met H&P Industries, Inc., finished goods specifications, H&P Industries, Inc. is voluntarily recalling all 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.
For further information, please view the following web site:
Please ensure those responsible are aware of this product recall advisory. Also review your supplies to determine whether or not the identified products are present. If the identified products are present, address appropriately.