Leiter's Compounding Pharmacy: Recall - Concerns of Sterility Assurance

AUDIENCE: Consumer, Pharmacy, Patient, Health Professional

ISSUE: Leiter's Compounding Pharmacy is voluntarily recalling 3 lots of its sterile products due to concerns of sterility assurance with Front Range Laboratories, Leiter's Compounding Pharmacy's independent testing laboratory. FDA investigators observed that methods used by the independent laboratory to assess sterility may have resulted in pharmacies receiving inaccurate laboratory test results. The FDA has concerns that results obtained from the laboratory are not reliable.

The use of a non-sterile injectable product exposes patients to the risk of contracting serious life-threatening infections.

BACKGROUND: These products were dispensed to health care providers between 8/05/13 to 9/02/13 nationwide throughout the United States.

RECOMMENDATION: Leiter's Compounding Pharmacy is notifying prescribing Physicians by first class mail, telephone, and/or email and is arranging for return of all recalled products. Facilities that have product which is being recalled should stop using and return to Leiter's Compounding Pharmacy.

To return product or request assistance related to this recall, users should contact Leiter's Compounding Pharmacy at 1-800-292-6772, Monday through Friday, between 8:00 a.m. and 5:00 p.m. PST.