In a press release, the U.S. Food and Drug Administration announced that a consent decree of condemnation, forfeiture, and permanent injunction has been filed against H&P Industries Inc., The Triad Group Inc., and three individuals who were responsible for producing and distributing s potentially contaminated with Bacillus cereus. Millions of products with the brand names of Triad Group,Cardinal Health, PSS Select, VersaPro, Boca/ Ultilet, Moore Medical, Walgreens, CVS and Conzellin were affected by the nation-wide recall.
Triad Group and H&P Industries of Hartland, Wisconsin, are accused of violiating good manufacturing standards and failing to heed FDA inspections and warnings about problems with contamination and sterility. Today’s actions mean that these groups cannot resume manufacturing and distributing drugs or medical devices until they establish an acceptable Quality Assurance and Quality Control program to ensure that all products manufactured in their facilities comply with federal standards for quality and have the identity, purity, potency and safety they are expected or are represented to possess. Additionally, about $6 million worth of products were seized by federal health officials over public safety fears.
A Industries have been sued by a Houston couple who blame the tainted pads for the death of their two-year-old son. The boy, who recently underwent surgery, was treated at the hospital with alcohol that were later recalled. The boy developed an infection with Bacillus cereus, and later died.