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.
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 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.
See all 10 products in this recall →Related recalls
Same manufacturer · SSM Health Care St. Louis DBA SSM St. Clare Health Center
See all →- HighPhenylephrine HCl Syringes Recalled for Sterility Assurance Failure
FDA (Drugs) · 2024-04-10
- HighInjectable Fentanyl Vials Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2024-04-10
- HighFDA Recalls Hydromorphone Injections Due to Discontinued Quality Assurance Program
FDA (Drugs) · 2023-06-07
- SeverePotassium Chloride Injection Recall Due to Sterility Assurance Lack
FDA (Drugs) · 2021-10-20
- ModerateSSM St. Clare Recalls Amiodarone Injectable Due to Sterility Concerns
FDA (Drugs) · 2018-01-03
Same hazard · microbial contamination
See all →- CriticalVictory Medical Center Pharmacy Recalls Glutathione Vials Due to Contamination
FDA (Drugs) · 2026-08-19
- HighMedline Medical Convenience Kits Recalled Due to Potential Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighMedline Convenience Kits Recalled Over Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15