FDA-Drug2018-01-03Class II
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
SSM Health Care St. Louis DBA SSM St. Clare Health Center
Hazard
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.
Sold states
SSM Health entities in the state of MO only
Affected count
N/A
Manufactured in
1015 Bowles Ave, N/A, Fenton, MO, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0137-2018Don't want to check this manually?
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