Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0137-2018·Announced 2018-01-03

SSM St. Clare Recalls Amiodarone Injectable Due to Sterility Concerns

SSM St. Clare Health Center is recalling a specific lot of compounded Amiodarone injectable bags due to a lack of sterility assurance. No distributed product has been confirmed to contain microorganisms.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is theoretical because no distributed product was confirmed to contain microorganisms, and no illnesses or injuries are reported, fitting the criteria for a voluntary precautionary recall or low-risk contamination.

Plain-English summary

SSM Health Care St. Louis, doing business as SSM St. Clare Health Center, is recalling Amiodarone 900 mg in dextrose 5% 500 mL bags. The product is a compounded injectable drug intended for hospital or office use only. The specific lot affected is 170711-005, with a date of 10/09/2017.

The recall was initiated due to a lack of sterility assurance. Microbial growth was detected during a routine simulation of the manufacturing process. The source text explicitly states that no batches of distributed product have been identified as actually containing microorganisms.

The product was distributed to SSM Health entities in the state of Missouri only. Because this is a compounded injectable drug for hospital or office use, it is not available to the general public. Healthcare facilities should stop using the affected lot and contact the recalling firm for instructions.

The recalled product

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
Manufacturer: SSM Health Care St. Louis DBA SSM St. Clare Health Center
Category: Drug — Injectable
Hazard: microbial-contamination
sterility-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot: 170711-005
10/09/2017

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 10 recalled by SSM Health Care St. Louis DBA SSM St. Clare Health Center under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

Same manufacturer · SSM Health Care St. Louis DBA SSM St. Clare Health Center

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