FentaNYL citrate — Class II drug recall D-0436-2024
Ongoing recall by SSM Health Care St. Louis DBA SSM St. Clare Health Center, reported 2024-04-10, distributed in MO. Lack of Assurance of Sterility: Firm did not perform process validation.
| Recall number | D-0436-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SSM Health Care St. Louis DBA SSM St. Clare Health Center, Fenton, MO, United States |
| Recall initiated | 2024-02-29 |
| Classified | 2024-04-04 |
| Reported by FDA | 2024-04-10 |
| Distributed | MO |
| Quantity | 140 vials |
| Reason classes | sterility |
| NDC | 60652-9010-01 |
| Lot numbers | 20231031-0C91D9 |
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
Reason for recall
Lack of Assurance of Sterility: Firm did not perform process validation.
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-0436-2024. 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.