Product: Amiodarone 900 mg in dextrose 5% 500 mL, 500 mL bag, Concentration: 1.8 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO.  --- NDC:  88890-0333-01
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