SSM St. Clare Recalls Fentanyl Vials Due to Sterility Assurance Concerns
SSM St. Clare Health Center is recalling Fentanyl 10 mcg vials because microbial growth was detected during a routine manufacturing simulation. No distributed product has been identified as containing 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 and no illnesses are reported, fitting the criteria for a voluntary precautionary recall or low-risk contamination.
Plain-English summary
SSM Health Care St. Louis DBA SSM St. Clare Health Center is recalling Fentanyl 10 mcg in 0.9% Sodium Chloride 1 mL vials. The recall is 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. It is distributed exclusively to SSM Health entities in the state of Missouri. The specific lot number is 170614-006, with an expiration date of 9/12/2017.
The source text states that no batches of distributed product have been identified as actually containing microorganisms. Healthcare facilities should discontinue use of the affected lot and contact the recalling firm for further instructions.
The recalled product
- Product
- Fentanyl 10 mcg in 0.9% Sodium Chloride 1 mL, 1 mL Vial, Concentration: 10 mcg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88890-9010-81
- Category
- Drug — 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 (2)
- Lot: 170614-006
- exp 9/12/2017
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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