IGMPI India

Unique Pharmaceuticals Ltd of Texas has recalled all non-expired, sterile drug products distributed across the U.S. market because of a lack of sterility assurance. The recalled products include Lot 86513, N-Acetyl Cysteine 20% and all other non-expired, purportedly sterile drug products. Unique Pharmaceuticals is a compounding pharmacy, which produces customized medications ordered by physicians.

FDA inspections revealed sterility failures in several lots of drug products intended to be sterile, recurring environmental contamination problems, and poor sterile production practices. Using these products may put patients at an unacceptable risk for serious infection. At the request of the FDA, Unique Pharmaceuticals agreed to the recall and is ceasing sterile compounding operations until sufficient corrections are made at its facility.The company has also stopped production of all other sterile drugs, which are generally solutions administered via injection or intravenous infusion.The company still continues to produce other forms of drugs that do not require sterile conditions.

Till date, there are no reports of any illnesses linked to the use of recalled products. Last week the FDA also warned physicians not to use drugs from another Texas compounding pharmacy, NuVision Pharmacy of Dallas, due to potential contamination.