Triad Wipes Recall Leads to Permanent Injunction Against Manufacturer
Federal regulators have put in place a permanent injunction against H&P Industries, which recalled tens of millions of infected Triad alcohol wipes, prep pads and other medical products earlier this year.
The FDA announced on June 13 that a consent decree consisting of a permanent injunction, condemnation and forfeiture will be put in place against H&P, which was manufacturing products sold under the Triad Group name.
The company is prevented from manufacturing until it has established that its products are safe and that a number of systemic production problems have been solved. H & P indicates that it plans to meet the FDA’s requirements and re-open its business in the future.
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The recalled Triad wipes, prep pads and swabs were commonly used in hospitals and packaged with a number of medications. They were also sold under variety of other labels, including CVS, Walgreens and Cardinal Health.
In April, H&P shut down when U.S. Marshals arrived with orders from the FDA to seize $6 million worth of H&P Industries products. On the same day, the FDA released an inspection report for the company’s Hartland, Wisconsin, production facility, which found that some products were still being contaminated with Bacillus cereus.
The consent decree requires H&P to hire an independent current good manufacturing practice (cGMP) expert who will develop a plan of corrective action to solve the company’s sterilization problems. If the company violates the decree it could face a number of penalties, including an order to cease manufacturing, forced product recalls and fines of $15,000 per day and $15,000 for each legal violation.
At least three Triad alcohol wipe lawsuits filed against the manufacturer; one by the parents of a two-year-old Houston boy who died due to a Bacillus cereus infection, another by a Tennessee man who alleges that a Triad alcohol prep pad infection left him permanently disabled, and a third that was filed by a 31-year-old Colorado woman with multiple sclerosis who alleges she contracted a life-threatening infection. The parents of a 10-year-old boy with leukemia who fell ill at The Children’s Hospital have also said they intend to file a lawsuit.
Bacillus cereus is responsible for about two percent of all foodborne illness, according to the CDC. Illness comes within 24 hours after exposure and can result in a diarrheal illness. Serious illness and permanent injury are very rare.
LisaJune 14, 2011 at 5:38 pm
A friend of mine developed a serious life threatening infection following the repeated use of these contaminated products, and following surgery for debridement of the infection, was given these products to use at home to clean around the large hole left in her stomach from these contaminated products. This recall was announced in January....My friend continued to receive these contaminated pr[Show More]A friend of mine developed a serious life threatening infection following the repeated use of these contaminated products, and following surgery for debridement of the infection, was given these products to use at home to clean around the large hole left in her stomach from these contaminated products. This recall was announced in January....My friend continued to receive these contaminated products and was never informed about the recall until 2 weeks ago.....The letter informing my friend about the recall came from a Medical Supply Company........
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