Unique Pharmaceuticals Ltd. is conducting a voluntary recall of its unexpired sterile products, after receiving a request to do so from the FDA.
The company, based in Temple, Texas, provides outsourced pharmacy services for hospitals and surgery centers across the United States.
Unique is initiating the recall after FDA inspections raised concerns about the sterility assurance associated with the manufacturer’s compounding facilities and processes, the agency said.
The FDA recommended that health care professionals should immediately check their medical supplies and quarantine any sterile drug products from Unique Pharmaceuticals. Do not administer them to patients as these products may be contaminated, the FDA said in a release.
Two recent inspections of the facility conducted by the FDA revealed unsanitary conditions that result in a lack of sterility assurance of drug products produced at the facility. These inspections found “sterility failures in several lots of drug products intended to be sterile, recurring environmental contamination problems, and poor sterile production practices,” according to the FDA.
“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, in Silver Spring, Md.
The recall involves a myriad of products, including lots of dexamethasone, dextrose 5% solution, fentanyl, ephedrine, heparin, lorazepam, morphine, nitroglycerin, polymyxin B and other products. (For a complete list of products and lot numbers, go to http://bit.ly/1tj1IwI).
To date, neither the company nor the FDA has received any reports of injury or illness associated with the use of its sterile preparations, and there is no evidence of contamination in any of Unique’s released sterile products, the company said in a release.
The recall includes all sterile compounded preparations that Unique has supplied to its customers within the expiry period. The affected products were distributed to hospitals and surgical centers nationwide in syringes, vials and bags.
Recall instructions for both controlled and non-controlled products are available online at http://bit.ly/1rTcZ4L. Fill out the required forms and e-mail them to email@example.com or fax to (888) 874-0616. The company will arrange the return of all products within the expiry period.