Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0139-2018·Announced 2018-01-03

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.

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

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.

See all 10 products in this recall →

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

See all →

High
Injectable Fentanyl Vials Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2024-04-10
High
Phenylephrine HCl Syringes Recalled for Sterility Assurance Failure
FDA (Drugs) · 2024-04-10
High
FDA Recalls Hydromorphone Injections Due to Discontinued Quality Assurance Program
FDA (Drugs) · 2023-06-07
Severe
Potassium Chloride Injection Recall Due to Sterility Assurance Lack
FDA (Drugs) · 2021-10-20
Moderate
SSM St. Clare Recalls Fentanyl Vials Due to Sterility Assurance Concerns
FDA (Drugs) · 2018-01-03

Same hazard · sterility