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More than $6 million in OTC and hospital medical supplies including medicated wipes and antifungal creams were seized by federal officials because the products may have contributed to serious infections and death. U.S. Marshals, acting on behalf of the Food and Drug Administration (FDA), raided the manufacturing plant of H&P Industries Inc. and the Triad Group collecting providone iodine and benzalkonium chloride antiseptic products, cold and cough medicines, nasal sprays, suppositories, medicated wipes, antifungal creams, and hemorrhoidal wipes. The products will be quarantined and processed for contaminants.
Since December 2010, FDA inspections at the plant identified the presence of microbial contamination and resulted in three voluntary recalls of Triad Group products, including alcohol prep pads, providone iodine prep pads, and lubricating jelly.
Subsequent inspections also found situations where firm officials knew the products were possibly contaminated but were still sent out for public distribution. The company’s repeated failure to correct these measures led the FDA to order the company to stop making and distributing the products. When the company did not comply, the FDA ordered the raid.
Testing found that wipes made at the facility were found to be contaminated with Bacillus cereus, a bacteria that was later linked to serious infections at a Colorado children’s hospital and in a Tennessee cardiac patient. The parents of a 2-year-old Houston boy sued the company after their son died from an infection caused by the bacteria that they say was transmitted by the contaminated wipes.
The wipes are sold under the Triad Group label and under the private labels of many major drug stores and grocery stores, including Walmart, CVS, Walgreens and Safeway. They are also used in hospitals and clinics.
For a complete list of recalled alcohol wipes, click here. http://www.triad-group.net/media/pdf/Recal_Facts.pdf
For a complete list of recalled providone iodine wipes, click here. http://www.triad-group.net/media/pdf/PVP_Prep_Recall_Ltr.pdf
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