Care-Tech agrees to stop making antimicrobials
This article was originally published in The Tan Sheet
Executive SummaryCare-Tech Laboratories will cease manufacturing, selling and distributing unapproved OTC antimicrobial gels, lotions and powders for the treatment and prevention of infection in part because FDA discovered good manufacturing discrepancies, the agency says Sept. 8. The St. Louis-based firm and its principals, John C. Brereton and Sherry L. Brereton, signed a consent decree, formally agreeing to abstain from the activities until correcting all violations. Additionally, the products do not conform to any applicable regulations for OTC drug products and FDA has not reviewed them - making them unapproved drugs. FDA says the firm's products are sold online and by phone to facilities. So far no injuries were reported. The agency asks consumers to contact the firm to return its products, including Barri-Care, Care-Creme, Clinical Care, Loving Lather and Techni-Care
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