HYDROmorphone HCl 10 mg in 0 — Class II drug recall D-0776-2023
Ongoing recall by SSM Health Care St. Louis DBA SSM St. Clare Health Center, reported 2023-06-07, distributed in MO. CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the ide
| Recall number | D-0776-2023 |
|---|---|
| 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 | 2023-05-09 |
| Classified | 2023-05-31 |
| Reported by FDA | 2023-06-07 |
| Distributed | MO |
| Quantity | 3,232 syringes |
| Reason classes | potency, cgmp |
| NDC | 60652-0600-02 |
| Lot numbers | 20220914-5D5AE0, 20220929-523FD5, 20221109-45BA60, 20221208-0F5483, 20230110-058361, 20230222-45AB24, 220502-024, 220510-035, 220526-015, 220811-010 |
| Expiration dates | 2022-10-29, 2022-11-06, 2022-11-22, 2023-02-07, 2023-03-13, 2023-03-28, 2023-05-08, 2023-06-06, 2023-07-09, 2023-08-21 |
Product
HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0600-2
Reason for recall
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
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-0776-2023. 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.