Product: Fentanyl 10 mcg in 0.9% Sodium Chloride 1 mL, 1 mL Vial, Concentration: 10 mcg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC:  88890-9010-81
Reason for recall: Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product  have been identified as actually containing microorganisms.
Recall initiated: 20170810
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated