The FDA is alerting healthcare professionals not to use drugs marketed as sterile by Unique Pharmaceuticals as they may be contaminated.
The FDA recently conducted two inspections of the Unique Pharmaceuticals facility and observed unsanitary conditions that resulted in a lack of sterility assurance. Inspections revealed sterility failures in several lots of drug products intended to be sterile, recurring environmental contamination problems, and poor sterile production practices. The FDA has requested the company to recall all non-expired lots of sterile drug products currently on the market. Also, the FDA has asked the company to stop sterile compounding operations until adequate corrections have been made at its facility.
Administration of non-sterile drug products intended to be sterile may result in serious and potentially life-threatening infections or death. Healthcare professionals are to immediately check their supplies and quarantine any sterile drug products from Unique Pharmaceuticals.
For more information visit FDA.gov.
UPDATE: A spokesperson for Unique Pharmaceuticals states that the company is disputing the FDA’s claim that the facility had unsanitary conditions leading to a lack of sterility assurance. The company asserts that every batch of drug products compounded at Unique Pharmaceuticals are tested for sterility.