SSM St. Clare Recalls Hydromorphone PCA Cartridges Due to Sterility Concerns
SSM St. Clare Health Center is recalling specific lots of compounded Hydromorphone PCA cartridges due to a lack of sterility assurance. No distributed product has been confirmed to contain microorganisms.
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 has been identified as containing microorganisms, making this a voluntary precautionary recall with no reported illness.
Plain-English summary
SSM Health Care St. Louis DBA SSM St. Clare Health Center is recalling specific lots of Hydromorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA cartridges. The recall was initiated due to a lack of sterility assurance, as microbial growth was detected during a routine simulation of the manufacturing process.
The affected product is a compounded injectable drug intended for hospital or office use only. The recall covers lots 170615-004 (expiration date 9/13/2017) and 170720-009 (expiration date 10/18/2017). The product was distributed exclusively to SSM Health entities within the state of Missouri.
The manufacturer states that no batches of distributed product have been identified as actually containing microorganisms. Healthcare facilities and patients who have received these specific lots should contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA, 50 mL Cartridge, Concentration: 0.2 mg/mL., This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-0600-01
- Category
- Drug — Compounded Injectable
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: 170615-004
- 9/13/2017
- 170720-009
- 10/18/2017
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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