For Immediate Release
July 23, 2014
The U.S. Food and Drug Administration is alerting health care professionals and consumers of a voluntary recall of all non-expired drug products produced for sterile use by Unique Pharmaceuticals Ltd., of Temple, Texas.
The recalled products include lot 86513, N-Acetyl Cysteine 20%, and all other non-expired, purportedly sterile drug products.
Health care professionals should immediately check their medical supplies, quarantine any sterile drug products from Unique Pharmaceuticals, and not administer them to patients, as these products may be contaminated. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.
Unique Pharmaceuticals distributed these products nationwide. Most of the product labels include: Unique Pharmaceuticals, Temple TX USA 76502.
Two recent inspections of the Unique Pharmaceuticals facility conducted by the FDA revealed insanitary conditions that result in a lack of sterility assurance of drug products produced at that facility. These inspections revealed sterility failures in several lots of drug products intended to be sterile, recurring environmental contamination problems, and poor sterile production practices.
On July 11, 2014 the FDA issued a formal request to Unique Pharmaceuticals to conduct a recall of all non-expired, purportedly sterile drug products. The FDA also requested that the firm cease sterile compounding operations. As a result of the FDA requests, Unique Pharmaceuticals has agreed to the recall and is ceasing sterile compounding operations until sufficient corrections are made at its facility.
“Using these products puts patients at an unacceptable risk for serious infection,” said Carol Bennett, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We urge health care professionals to follow recall instructions issued by the firm.”
To date, the 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.
The FDA asks health care professionals and consumers to report adverse events or quality problems associated with the use of Unique Pharmaceuticals’ products to the FDA’s MedWatch Adverse Event Reporting program by:
- completing and submitting the report online at MedWatch Online Voluntary Reporting Form; or
- 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 Nov. 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 the FDA according to a risk-based schedule; and
- must meet certain other requirements, such as reporting adverse events and providing the FDA with certain information about the products they compound.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.