Fentanyl 10 mcg in 0 — Class II drug recall D-0136-2018
Terminated recall by SSM Health Care St. Louis DBA SSM St. Clare Health Center, reported 2018-01-03. Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing proces
| Recall number | D-0136-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SSM Health Care St. Louis DBA SSM St. Clare Health Center, Fenton, MO, United States |
| Recall initiated | 2017-08-10 |
| Classified | 2017-12-28 |
| Reported by FDA | 2018-01-03 |
| Terminated | 2018-03-22 |
| Reason classes | microbial contamination, sterility |
| NDC | 88890-9010-81 |
| Lot numbers | 170614-006 |
| Expiration dates | 2017-09-12 |
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
Reason for recall
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0136-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.