# FDA recall D-0776-2023

> **SSM Health Care St. Louis DBA SSM St. Clare Health Center** · Class II · drug recall initiated 2023-05-09.

## 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.

## Distribution

Product was distributed in Missouri.

## Key facts

- **Recall number:** D-0776-2023
- **Recalling firm:** SSM Health Care St. Louis DBA SSM St. Clare Health Center
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-05-09
- **Report date:** 2023-06-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fenton, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0776-2023

## Citation

> AI Analytics. FDA recall D-0776-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0776-2023. Source: US FDA. Licensed CC0.

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