Care-Tech Laboratories, makers of Techni-Care pre-operative prep solutions and surgical scrub and several other over-the-counter antimicrobial drugs used to treat and prevent infection, has signed a consent decree, agreeing to stop the illegal manufacture, marketing and distribution of its products, says the U.S. Food and Drug Administration.
FDA inspectors found that Care-Tech violated numerous provisions of the FDA's current good manufacturing practice (cGMP) regulations that direct how antimicrobial drugs are made. Additionally, the products do not conform to any applicable regulations for OTC drug products and have not undergone an FDA review, and therefore are considered unapproved drug products.
Under the terms of the consent decree, Care-Tech may not resume manufacturing and distribution of the drugs until it corrects these and other violations. Neither FDA nor Care-Tech is aware of any reports of injury or illness related to the use of these products, and FDA has not issued a product recall. "The company is committed to ensuring that each of its products reflects the highest standards of safety and purity," says John C. Brereton, the president of Care-Tech.
Dan O'Connor
