RECALL: H&P Industries Recalls Povidone Iodine Products Due to Inadequate Microbial Testing

H&P Industries recalled all lots (lots beginning with 8J-8M, 9A-9M, 0A-0M, 1A-1C) of Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel. H & P Industries 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. Patients undergoing medical and surgical procedures, including those who are immunocompromised, have a high risk of infection from antiseptic surgical preparation that have been prepared, packaged, or held under insanitary conditions.

For more information visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm269800.htm