Injectable Fentanyl Vials Recalled Due to Sterility Assurance Failure
SSM Health Care is recalling 140 vials of fentanyl citrate injection because the manufacturer did not perform required process validation to ensure sterility.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves lack of sterility assurance in an injectable medication. Although no illnesses or injuries have been reported, the hazard is serious: injectable fentanyl with unvalidated sterilization poses potential for patient harm. Per the rubric, this is High severity due to a risk-of-harm product without reported injury.
Plain-English summary
SSM Health Care St. Louis is recalling 140 vials of fentanyl citrate injection (NDC: 60652-9010-1). The product is intended for intravenous use in hospital and office settings only.
The recall was initiated because the manufacturer failed to perform process validation, a required quality control procedure. Without process validation, there is no assurance that injectable medications maintain the sterility required for patient safety.
The affected lot (20231031-0C91D9) expired February 29, 2024. Distribution was limited to Missouri. Healthcare facilities should immediately quarantine any remaining vials from this lot and contact the manufacturer for return instructions.
The recalled product
- Product
- FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx Only, Hospital/Office Use Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-9010-1
- Category
- Drug — Injectable Fentanyl
- Affected units
- 140
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: 20231031-0C91D9
- Exo 29-Feb-2024.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 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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