The FDA alerted 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. 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 unsanitary conditions that result in a lack of sterility assurance of purportedly sterile drug products produced by the company, which puts patients at risk. 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 10, 2014, the FDA asked the company to recall all non-expired lots of sterile drug products, but the company refused to do so. July 11, 2014, the FDA issued a formal request for Unique Pharmaceuticals to recall all non-expired lots of its sterile products currently on the market. The FDA 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.
See the FDA Safety Alert
See the FDA Drug Alert
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication