The Food and Drug Administration asked the United States (U.S. Marshalls) to stop distribution of all medical supplies from the makers of potentially contaminated drug products, blamed for serious infections and death. The products were manufactured in violation of federally mandated manufacturing requirements.
H&P Industries Inc. and Triad Group, who are owned and managed by the same parties, have been under fire over the past few months due to contamination concerns that have prompted multiple recall notices. Earlier this weeks, the U.S. Marshalls seized $6 million in products from the Hartland, Wisconsin company. The products included povidone-iodine and benzalkonium chloride antiseptic products, cough and cold products, nasal sprays, antifungal creams, suppositories, medicated wipes, hemorrhoidal wipes, in-process drug products, and raw materials.
The decision to seize the products was prompted due to the continued failure of H&P Industries to comply with the FDA’s current good manufacturing practice (cGMP) regulations. The regulations are intended to assure the quality, purity and safety of the manufactured drugs.
According to a press release on the FDA’s site, “[The] FDA completed its most recent inspection of H&P Industries on March 28, 2011. The inspection found multiple violations of cGMP requirements, including continuing problems with the air handling system; failure to adequately investigate drug products that did not meet specifications affecting the majority of the products manufactured at the facility; and failure to take the proper measures to ensure the quality of incoming components.”
If you have sustained severe injuries after using a recalled product manufactured by Heartland Industries, contact defective product lawyers at Burnetti, P.A.