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Care-Tech agrees to stop distributing OTC antimicrobial drugs

This article was originally published in The Gold Sheet

Executive Summary

St. Louis-based Care-Tech Laboratories Inc. and its principal officers have agreed to stop manufacturing and distributing their line of over-the-counter antimicrobial drugs under the terms of a recently signed consent decree with FDA until certain problems are remedied. Sixteen antimicrobial drugs used to treat and prevent topical infection are affected by the action. FDA inspectors found that Care-Tech violated numerous provisions of the cGMP regulations that direct how antimicrobial drugs are made. Additionally, inspectors found that the products did not conform to any applicable regulations for OTC drug products and did not undergo FDA review, and therefore are considered unapproved drug products. "FDA is concerned about Care-Tech's products because they lack FDA approval, do not conform to any applicable over-the-counter monograph, and are not appropriately manufactured," said Deborah Autor, director of the Office of Compliance in FDA's Center for Drug Evaluation and Research. Care-Tech products are sold online and through telephone orders to hospitals, nursing homes and other health care facilities. The firm has had a relatively clean safety record and has not had any problems since 2000, when its Techni-Care antiseptic was recalled due to microbial contamination (see 1"The Gold Sheet," March 2001)
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