St. Louis-based Care-Tech Laboratories Inc. and its principal officers, John C. Brereton and Sherry L. Brereton, have agreed to stop the illegal manufacture, marketing, and distribution of over-the-counter antimicrobial drugs used to treat and prevent infection.
The Food and Drug Administration (FDA) says its inspectors found that Care-Tech violated numerous provisions of the agency's current good manufacturing practice (cGMP) regulations that direct how antimicrobial drugs are made.
Additionally, it says 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 a consent decree, Care-Tech may not resume manufacturing and distribution of the drugs until it corrects these and other violations.
"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," said Deborah Autor, director of the FDA's Office of Compliance, Center for Drug Evaluation and Research. "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."
Care-Tech products are sold online and through telephone orders to hospitals, nursing homes and other health care facilities. They are not sold in retail stores.
The FDA says it is not aware of any reports of injury or illness related to the use of these products. The agency advises consumers to contact Care-Tech at 1-800-325-9681 to return products in their possession, which include:
• Caricia Care
• Clinical Care
• Formula Magic
• Loving Lather
• Loving Lather II
• Loving Lotion
• Orchid Fresh II
• Tech 2000
• Urban Skin
Health care professionals and consumers may report serious side effects or quality problems for these or any products to the FDA's MedWatch Adverse Event Reporting program, online, or by regular mail, fax or phone.
• Online: http://www.fda.gov/Safety/MedWatch/default.htm
• Regular Mail: use postage-paid FDA form 3500 available at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: 800-FDA-0178
• Phone: 800-FDA-1088