Last week, federal health regulators asked H&P Industries Inc. to stop making and distributing alcohol swabs and other medical product after an inspection of its Wisconsin facility turned up â€œevidence that shows this firm made and distributed products with a variety of opportunistic pathogens.â€ Yesterday, federal Marshalls visited that facility with orders to seize products, and H&P Industries, which does business as Triad Group, decided to comply with the Food & Drug Administration’s (FDA) request that it stop production.
Over the past few months, Triad Group has issued several massive recalls of <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">tainted alcohol prep pads, alcohol swabs, and alcohol swabsticks, as well as lubricating jelly products, sold under various brand names because of potential contamination with the bacteria Bacillus cereus. Last month. H&P Industries issued a Povidine Iodine Prep Pad recall because of concerns that they could be contaminated with Elizabethkingia meningoseptica, a type of bacteria associated with flesh eating bacteria disease, meningitis in newborn infants and pneumonia in patients on ventilators. Many of the products, which bore the Triad brand name and various other private labels, were sold at drugstores and grocery stores, including Walgreens, CVS and Walmart. They were also widely used in hospitals and clinics.
The company has also been named in at least three lawsuits that claim the tainted products caused serious injuries and deaths. One of the lawsuits blames tainted Triad wipes for the death of a 2-year-old boy. That suit claims the wipes were the likely source of bacterial meningitis that killed the child.
In the midst of the recalls, Triad had already shut down one production line after it was found to be contaminated. According to MSNBC, the company waited to shut down the entire facility until the FDA sent federal Marshalls there yesterday. H&P officials, however, are characterizing the shutdown as “voluntary.”
MSNBC is also reporting that the FDA posted documents on its website yesterday detailing problems with more Triad products. According to those documents, contamination was detected in the firm’s antiseptic towlettes and in raw materials used to make over-the-counter fiber products often used as laxatives and to lower cholesterol. In addition, inspectors found serious and systemic problems with the firm’s “high purity” water system.
Among other things, inspectors identified pad material and foil packaging used in the alcohol prep wipes as the potential cause of the contamination of antiseptic towlettes, with implications for other products. They also found that several batches of over-the-counter products, including hemorrhoidal suppositories and Triad PVP Swabsticks, failed to remain stable or failed to meet standards for active ingredients.
According to a report in the Milwaukee Journal-Sentinel, it’s rare for the FDA and U.S. Marshals to seize materials at a medical products plant. Normally, problems are resolved well before there’s a plant shutdown or product seizure. In 2010, for example, there were just 10 seizures in the food, drugs and medical-device industries.