FDA recall D-0137-2018

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.

Distribution

SSM Health entities in the state of MO only

Key facts

Status

Terminated

Initiation date

2017-08-10

Report date

2018-01-03

Termination date

2018-03-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fenton, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0137-2018