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:
Loving Lather II
Orchid Fresh II
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
Media Inquiries: Christopher Kelly, 301-796-4676
Consumer Inquiries: 888-INFO-FDA