ST. LOUIS, MO, September 14, 2009/ – - Care-Tech^® Laboratories, Inc. announces that it has suspended manufacturing and distribution of its drug products to address concerns raised by the U.S. Food and Drug Administration (FDA). Specifically, the FDA has informed Care-Tech^® that it believes the company’s over-the-counter (OTC) drug products have not been manufactured, processed, packed, and held consistent with current good manufacturing practice for drugs, which makes them presumptively adulterated under the law, even where, as here, no finished product has been found to be defective. FDA also has informed Care-Tech^® that it believes these products do not conform to an OTC drug monograph, and so are considered unapproved drugs. Accordingly, Care-Tech^® has agreed to suspend manufacturing and distribution of our drug products until we have fully resolved these concerns. Care-Tech^® has already taken significant steps to address the issues FDA has brought to our attention, and we are working closely with agency officials to ensure any remaining issues are resolved as expeditiously as possible.

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 requested that previously distributed product be recalled. “The company is committed to ensuring that each of its products reflects the highest standards of safety and purity,” says John C. Brereton, President. “For over 100 years, patient safety has been Care-Tech^® Laboratories’ first and foremost commitment. And I can assure you, it remains so today.”

The company intends to update its customers as further information becomes available.

For Immediate Release: Sept. 8, 2009

Media Inquiries: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

Care-Tech Laboratories Agrees to Stop Making, Selling and Distributing Unapproved Antimicrobial Products

The U.S. Food and Drug Administration today announced that St. Louis-based Care-Tech Laboratories Inc. and its principal officers, John C. Brereton and Sherry L. 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.

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.

“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 is not aware of any reports of injury or illness related to the use of these products. Consumers should contact Care-Tech at 1-800-325-9681 to return products in their possession, which include:

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
Urban Skin

Health care professionals and consumers may report serious adverse events (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

For more information:

Facts About Current Good Manufacturing Practices (cGMPs) http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm169105.htm