The FDA is alerting healthcare professionals and consumers of a voluntary recall of all non-expired drug products for sterile use by Unique Pharmaceuticals, as they may be contaminated.
Two recent inspections of Unique’s facility 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, sterile drug products. The FDA also requested that Unique 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.
The recalled products include N-Acetyl Cysteine 20% Lot #86513, and all other non-expired, purportedly sterile drug products.
Administration of non-sterile drug products intended to be sterile may result in serious and potentially life-threatening infections or death. Healthcare professionals should immediately check their medical supplies, quarantine any sterile drug products from Unique Pharmaceuticals, and not administer them to patients.
For more information visit the FDA Safety Alert page.