Federal officials on Wednesday seized more than $6 million in medical supplies distributed by a Wisconsin firm whose potentially contaminated drug products are blamed for serious infections and death.
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U.S. Marshals, acting at the request of the federal Food and Drug Administration, seized a wide range of intimate care products manufactured and distributed by H&P Industries Inc. and the Triad Group of Hartland, Wis., FDA officials said.
They included povidone iodine and benzalkonium chloride antiseptic products, cough and cold medicines, nasal sprays, suppositories, medicated wipes, antifungal creams and hemorrhoidal wipes. Marshals also quarantined products that were still being processed as well as raw materials.
"We took this action to stop Triad from continuing to distribute products which may pose a risk to public health," Dara Corrigan, FDA commissioner for regulatory affairs, said in a statement.
The move comes two days after H&P Industries officials confirmed that U.S. Marshals had entered the plant with seizure orders. In a letter to customers and vendors sent Tuesday and obtained by msnbc.com, firm officials said they wanted to avert such action.
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"We had hoped and believed that our continued efforts to comply with corrective actions would allow us to continue to service the trade. That is not the case," wrote Mary Aagesen, vice president for Triad Pharmaceuticals. "We are, of course, deeply disappointed in this outcome."
FDA officials said the seizure follows the firm's continued failure to comply with current good manufacturing practice or cGMP, regulations. The agency last week asked H&P Industries to voluntarily cease making and distributing drug products, but the firm did not heed the request.
FDA inspections at the plant led to three voluntarily recalls of Triad Group products since December 2010, including massive recalls of alcohol prep pads, povidone iodine prep pads and lubricating jelly because of problems with microbial contamination.
Investigators also found systemic problems that included issues with sterility and contamination and situations in which firm officials knew products were possibly tainted and sent them for public distribution anyway.
An inspection that concluded March 28 found problems with the firm's air handling and water systems and "failure to take proper measures to ensure the quality of incoming components," the FDA said.
Pad material, foil packaging are culprits
The investigation found that pad material and foil packaging were the source of contamination of alcohol prep wipes with the bacteria Bacillus cereus, which was later linked to serious infections caused by the same bacteria in wipes at a Colorado children's hospital and in a Tennessee cardiac patient.
Parents of a 2-year-old Houston boy also sued the firm after the toddler died in December from an infection caused by Bacillus cereus they claim was transmitted by tainted wipes.
However, FDA officials knew about problems with contamination and sterilization at the Hartland plant dating back to 2009, inspection documents showed. They allowed H&P Industries officials to voluntarily correct problems because they believed there was no imminent public health hazard, according to Michael Rogers, the FDA's acting director of the Office of Regional Operations.
The U.S. Marshals, the FDA and the U.S. Attorney for the Eastern District of Wisconsin cooperated in Wednesday's investigation and seizure. The actual products are seized in place and quarantined at the site under court custody. The FDA's investigation remains open, spokeswoman Shelly Burgess said Wednesday.
H&P Industries Inc. and Triad Group are firms owned and operated by brothers David Haertle and Eric Haertle of Wisconsin and their sister, Donna Petroff, of Antioch, Ill. The firms' products are sold under the Triad Group label and under the private labels of many major drug stores and grocery stores, including Walgreens, CVS, Safeway and Walmart. They are also widely used in hospitals and clinics.
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