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.
What this means for you
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
- Category
- Drug — Compounded Injectable
- Hazard
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.
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