July 14, 2014
Sterile Drug Products by Unique Pharmaceuticals Ltd.: Recall - Lack of Sterility Assurance
AUDIENCE: Risk Manager, Health Professionals, Pharmacy
ISSUE: The U.S. Food and Drug Administration is alerting 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.
Health care professionals should immediately check their medical supplies, quarantine any sterile drug products from Unique Pharmaceuticals, and not administer them to patients. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death. To date, FDA is not aware of reports of illness associated with the use of these products.
BACKGROUND: 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 insanitary conditions that result in a lack of sterility assurance of purportedly sterile drug products produced by the company, which puts patients at risk (Form FDA-483s issued April 4, 2014 and June 20, 2014). These inspections revealed sterility failures in several lots of drug products intended to be sterile, recurring environmental contamination problems, and poor sterile production practices.
RECOMMENDATION: Patients who have received any drug product produced by Unique Pharmaceuticals and have concerns should contact their health care professional.The FDA asks health care providers and consumers to report adverse events or quality problems experienced with the use of any Unique Pharmaceuticals' products to the FDA’s MedWatch Adverse Event Reporting program:
• Complete and submit the report online at www.fda.gov/medwatch/report.htm
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.
Read the MedWatch Safety Alert, including links to the CDER Statement and FDA-483s, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm404786.htm