Unique Pharmaceuticals, Ltd. just announced a nationwide recall of all of its sterile compounded preparations within those preparations’ expiry period over a potential lack of sterility assurance, the U.S. Food and Drug Administration (FDA) just revealed.
The sterile drug preparations compounded by the outsourcing facility have not reached the expiration date listed on the products. Unique Pharmaceuticals indicated that it initiated the recall following FDA concerns with Unique Pharmaceuticals’ compounding facilities and processes. According to the agency, the facilities and processes present a lack of sterility assurance and were also observed during recent inspections conducted by the FDA.
Should a sterile product become compromised, patients become at risk for serious and potentially life-threatening infections. To date, Unique Pharmaceuticals has not received injury or illness reports associated with the use of its purportedly sterile preparations.
The FDA indicated that the recall includes all sterile compounded preparations supplied by Unique Pharmaceuticals to its customers within expiry dates and includes products distributed in syringes, vials, and bags that were released nationwide. Non-sterile preparations are not involved in the recall. The recalled products include lot 86513, N-Acetyl Cysteine 20 percent, as well as all other non-expired sterile drug products. The recalled products may be identified by the label, which includes the registration, “Unique Pharmaceuticals, Temple TX USA 76502,” according to BioNews Texas.
Health care providers should stop using all lots of sterile products that have been prepared by Unique Pharmaceuticals and that are within their expiry period. The products should be returned to Unique Pharmaceuticals, the FDA wrote. Unique Pharmaceuticals also indicated that it will advise its customers by telephone, fax, mail, or personal visits concerning return of the products to the company. According to BioNews Texas, the FDA also warned that any recalled products should be quarantined and not administered to patients.
“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.”
The FDA recently conducted two inspections at the Unique Pharmaceuticals facility that evaluated a number of sterility failures in various lots of drug products meant to be sterile. The agency also evaluated recurring environmental contamination problems and poor sterile production practices, wrote BioNews Texas.
In addition to its recall, Unique Pharmaceuticals is also ceasing all sterile compounding operations pending completion of the required corrections needed based on the FDA’s requests. The FDA issued a formal request to Unique Pharmaceuticals in early July that it conduct a recall of all of its non-expired, purportedly sterile drug products. Earlier this year, the firm announced it was in the process of working to ensure compliance with the enacted Drug Quality and Security Act, and also indicated it would voluntarily register with the FDA as a Human Drug Compounding Outsourcing Facility, BioNews Texas indicated.
Unique Pharmaceuticals may be reached by telephone, toll-free, at 1.888.339.0874, from 9:00 a.m. to 5:00 p.m., Central Standard Time (CST), Monday through Friday, or by email at email@example.com.