FDA alerts health care professionals not to use sterile drugs from Unique Pharmaceuticals
[7/11/2014] The U.S. Food and Drug Administration is alerting health care professionals, including hospital supply managers and hospital staff, not to use drugs marketed as sterile produced by Unique Pharmaceuticals Ltd., a company located in Temple, Texas, as they may be contaminated.
Health care professionals should immediately check their medical supplies, quarantine any sterile drug products from Unique Pharmaceuticals, and not administer them to patients. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.
Unique Pharmaceuticals’ products were distributed nationwide. Most of the product labels include: Unique Pharmaceuticals, Temple TX USA 76502.
FDA investigators conducted two recent inspections of the Unique Pharmaceuticals facility and observed insanitary conditions that result in a lack of sterility assurance of purportedly sterile drug products produced by the company, which puts patients at risk (Form FDA-483s issued April 4, 2014 (PDF - 4.28MB), and June 20, 2014 (PDF - 1MB)). These inspections revealed sterility failures in several lots of drug products intended to be sterile, recurring environmental contamination problems, and poor sterile production practices.
Yesterday, FDA asked the company to recall all non-expired lots of sterile drug products, but the company refused to do so. Today, FDA issued a formal request for Unique Pharmaceuticals to recall all non-expired lots of its sterile products currently on the market. FDA has also asked the company to cease sterile compounding operations until sufficient corrections are made at its facility. However, Unique Pharmaceuticals has refused to cease sterile compounding operations.
To date, FDA is not aware of reports of illness associated with the use of these products.
Patients who have received any drug product produced by Unique Pharmaceuticals and have concerns should contact their health care professional.
FDA asks health care professionals and consumers to report adverse events or quality problems associated with the use of Unique Pharmaceuticals’ products to FDA’s MedWatch Adverse Event Reporting program by:
- Completing and submitting the report online at MedWatch Online Voluntary Reporting Form
- Downloading and completing the form (PDF - 1.22MB), then submitting it via fax at 1-800-FDA-0178
Unique Pharmaceuticals is registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) as an outsourcing facility. The Drug Quality and Security Act, signed into law on November 27, 2013, added a new section 503B to the FDCA. Under section 503B, a compounder can elect to become an outsourcing facility. Outsourcing facilities:
- must comply with current good manufacturing practice requirements;
- will be subject to inspection by FDA according to a risk-based schedule; and
- must meet certain other requirements, such as reporting adverse events and providing FDA with certain information about the products they compound.