Povidone Iodine Recalled Due to Lack of Inspection
In a press release, H&P Industries Inc, a manufacturer of over-the-counter drug products, announced the voluntary recall of all lots of Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions and Prep Gels in cooperation with the US Food and Drug Administration (FDA) due to the lack of oversight infrastructure at the time of production.
The recall of these Povidone Iodine products is being initiated because H&P Industries produced them without having a system in place for microbial testing at the time of release, having a system in place to test incoming components and without having procedures set and in place to prevent objectionable microorganisms in these products. The company has conducted an extensive investigation and testing and has not found any evidence of contamination.
The Povidone Iodine products have been labeled as antiseptic for preparation of the skin prior to surgery and also for the use in the prevention of infection in minor cuts, scrapes and burns. The main use of the Povidone Iodine Scrub Solutions is as a surgical hand scrub for medical professionals. Patients having medical and surgical procedures performed, including those that are immunocompromised, have a high risk of infection from antiseptic surgical preparations that have been prepared, packaged or held in unsanitary condition and are considered injurious to health.
The company, to date, has received no reports of adverse effects or contamination in relation to this recall.
As a Los Angeles personal injury attorney, I’ve seen recalls like this in the past and know that pharmaceutical manufacturers rigorously test their products prior to distribution. Still, mistakes are possible in even the most strenuous production processes. If you’ve suffered adverse effects from a contaminated drug product, it may be in your best interests to speak with an experienced product defect lawyer.