Drug Maker Care-Tech Labs Agrees to Stop Producing Unapproved Antimicrobial Products

Care-Tech Laboratories, a St. Louis-based drug manufacturer, has agreed to stop making and distributing over-the-counter antimicrobial products for treating and preventing infection that have not been approved by the Food and Drug Administration.

Recent FDA inspections of Care-Tech Labs’ production facilities have uncovered violations of the agency’s rules for producing and distributing drug products, officials said. Also, the products Care-Tech makes do not meet FDA requirements for over-the-counter drugs and have not undergone FDA review, which makes them unapproved drug products, the 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,” 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.”

The following brand names of over-the-counter Care-Tech microbial products are involved in today’s actions and should not be used by consumers, the FDA said:

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

According to a consent decree signed by Care-Tech and announced today by the FDA, the company will stop manufacturing and distributing the drug products until all violations are corrected and the proper regulatory approvals are obtained.

Care-Tech sells its products both over the Internet as well as through telephone orders to hospitals, nursing homes, and other health care facilities. The products are not sold in retail stores or pharmacies, the FDA said.

The FDA is not aware of any reports of injury or illness related to the use of these products, but the agency is interested in hearing from consumers or physicians who know of related injuries.

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