Care-Tech Signs Consent Decree With FDA

The FDA has reported that Care-Tech Laboratories (Care-Tech) and its principal officers, John Brereton and Sherry Brereton, have signed a consent decree, agreeing to stop the illegal manufacture, marketing, and distribution of over-the-counter (OTC) antimicrobial drugs used to treat and prevent infection.

Reportedly, the inspectors found that Care-Tech violated numerous provisions of the FDA’s current good manufacturing practice (cGMP) regulations. 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.

The FDA has reported that it is not aware of any reports of injury or illness related to the use of these products. The FDA has alleged the customers to return the products which inlclude:Barri-Care, Care-Crème,Caricia Care, CC-500, Clinical Care, Consept, Formula Magic, Humatrix, Loving Lather, Loving Lather II, Loving Lotion, Orchid Fresh II, Satin, Tech 2000, Techni-Care and Urban Skin to return the products to the company.

Deborah Autor, director of the office of compliance of center for drug evaluation and research at FDA, said: “The FDA is concerned about Care-Tech’s products because they lack FDA approval, do not conform to any applicable over-the-counter drug monograph, and are not appropriately manufactured. Companies have an obligation to consumers to ensure that their products are safe, effective, and high quality, and the FDA recommends that Care-Tech’s customers seek alternative products.”