Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0140-2018·Announced 2018-01-03

SSM St. Clare Recalls Morphine PCA Cartridges Due to Sterility Concerns

SSM St. Clare Health Center is recalling specific lots of compounded Morphine PCA cartridges due to a lack of sterility assurance detected during routine testing.

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, but the source explicitly states that no distributed product was found to contain microorganisms, making this a voluntary precautionary recall with low risk of actual harm.

Plain-English summary

SSM Health Care St. Louis, doing business as SSM St. Clare Health Center, is recalling specific lots of Morphine 50 mg in 0.9% Sodium Chloride 5 mL PCA cartridges. The product is a compounded injectable drug intended for prescription use in hospitals and offices. The recall is limited to SSM Health entities in the state of Missouri.

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.

Affected lots include those with expiration dates of September 25, 2017, and September 27, 2017. Healthcare facilities should stop using the affected product and contact the recalling firm for further instructions.

The recalled product

Product: Morphine 50 mg in 0.9% Sodium Chloride 5 mL PCA, 50 mL Cartridge, Concentration: 1 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88887-6795-01
Manufacturer: SSM Health Care St. Louis DBA SSM St. Clare Health Center
Category: Drug — Compounded Injectable
Hazard: microbial-contamination

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 (5)

Lot
exp: 170627-012
9/25/2017
170629-019
9/27/2017

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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Same hazard · microbial contamination