Care-Tech Laboratories to Discontinue Unapproved Antimicrobial Products

The Food and Drug Administration recently 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 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. 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, and Urban Skin.

Download Center

HTML - No Current Item Deck
  • Free Safety Management Software Demo

    IndustrySafe Safety Management Software helps organizations to improve safety by providing a comprehensive toolset of software modules to help businesses identify trouble spots; reduce claims, lost days, OSHA fines; and more.

  • Get the Ultimate Guide to OSHA Recordkeeping

    When it comes to OSHA recordkeeping there are always questions regarding the requirements and in and outs. IndustrySafe is here to help. We put together this page with critical information to help answer your key questions about OSHA recordkeeping.

  • Safety Training 101

    When it comes to safety training, no matter the industry, there are always questions regarding requirements and certifications. We put together a guide that’s easy to digest so you can ensure you're complying with OSHA's training standards.

  • Conduct EHS Inspections and Audits

    Record and manage your organization’s inspection data with IndustrySafe’s Inspections module. IndustrySafe’s pre-built forms and checklists may be used as is, or can be customized to better suit the needs of your organization.

  • Track Key Safety Performance Indicators

    IndustrySafe’s Dashboard Module allows organizations to easily track safety KPIs and metrics. Gain increased visibility into your business’ operations and safety data.

  • Industry Safe
comments powered by Disqus