US Drug Recall Register
Class II · Moderate risk Terminated Initiated Aug 10, 2017 (9 years ago)

Amiodarone 900 mg in dextrose 5% 500 mL, 500 mL bag, Concentration: 1.8 mg/mL, This is a…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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.

What was recalled

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

Recalling firm
SSM Health Care St. Louis DBA SSM St. Clare Health Center
Origin
MO, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0137-2018

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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