Recall archive / FDA drug enforcement
HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation Out... — FDA record D-0776-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 9, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- 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.
- Classification
- Class II
- Recalling firm
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Quantity
- 3,232 syringes
- Agency-reported status
- Ongoing
- Source record identifier
- D-0776-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot #: 20230222-45AB24, BUD: 8/21/2023; Lot #: 20230110-058361, BUD: 7/9/2023; Lot #: 20221208-0F5483, BUD: 6/6/2023; Lot #: 20221109-45BA60, BUD: 5/8/2023; Lot #:20220929-523FD5, BUD: 3/28/2023; Lot#: 20220914-5D5AE0, BUD: 3/13/2023; Lot #: 220502-024, BUD: 10/29/2022; Lot #: 220510-035, BUD: 11/6/2022; Lot #: 220526-015, BUD: 11/22/2022; Lot#: 220811-010, BUD: 2/7/2023 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Product was distributed in Missouri.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jun 7, 2023
- Recall initiation date
- May 9, 2023
- Center classification date
- May 31, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.