The Food and Drug Administration (FDA) is warning health professionals, pharmacies and consumers not to use drugs marked as sterile manufactured by Unique Pharmaceuticals Ltd., because they may be contaminated and using them may result in serious and potentially life threatening infections or death.
The FDA conducted two recent inspections of Unique Pharmaceuticals and found unsanitary conditions that inspectors say could compromise the sterility of the purportedly sterile products, which puts patients at risk. The inspections revealed sterility failures in several lots of drug products intended to be sterile, reoccurring contamination problems, and poor sterile production practices.
Unique Pharmaceuticals’ products were distributed nationwide and most of the labels are imprinted with “Unique Pharmaceuticals, Temple TX USA 76502.” Unique Pharmaceuticals is a compounding pharmacy, a specialized company that mixes FDA-approved drug ingredients per a doctor’s orders. Many compounding pharmacies, however, have begun mass-producing compounded drug products and distributing them across state lines.
In 2012, hundreds of people were sickened and several were killed after developing with fungal infections including fungal meningitis after receiving contaminated steroid shots made by New England Compounding Center (NECC). This led to closer government oversight into compounding pharmacies that mass-produce these products. Previously, all compounding pharmacies were overseen by state pharmacy boards.
Health care professionals are advised to check their medical supplies and quarantine any sterile drug products from Unique Pharmaceuticals. Patients who have these products and have concerns should contact their doctors.
Any side effects from these drug products should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.