Drug recall
HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care…
FDA recall event 92395 · Class II · SSM Health Care St. Louis DBA SSM St. Clare Health Center
Key facts
| Event ID | 92395 |
|---|---|
| Recall numbers | D-0776-2023 |
| Recalling firm | SSM Health Care St. Louis DBA SSM St. Clare Health Center |
| Product type | Drugs |
| Products | 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 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| 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… |
| Initiation date | May 9, 2023 |
| Report date | Jun 7, 2023 |
| City | Fenton |
| State | MO |
| Country | United States |
| FEI number | 1972829 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: