Food, drugs, devices › SSM Health Care St. Louis DBA SSM St. Clare Health Center
Drug recall: HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation Outsou
FDA enforcement event 92395 is a drug recall by SSM Health Care St. Louis DBA SSM St. Clare Health Center of Fenton, MO, initiated 9 May 2023 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 59% of the 281 drug enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. SSM Health Care St. Louis DBA SSM St. Clare Health Center has 4 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
SSM Health Care St. Louis DBA SSM St. Clare Health Center, Fenton, MO.
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0776-2023 | 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 | 3,232 syringes | Class II | Ongoing | 7 Jun 2023 |
Context
Other enforcement events for SSM Health Care St. Louis DBA SSM St. Clare Health Center
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 29 Feb 2024 | Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This | Drug | Class II | 2 |
| 22 Sep 2021 | Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS, 250 mL bag, Rx Only, SSM Health Care Corporation, 1015 Bowl | Drug | Class II | 1 |
| 10 Aug 2017 | Fentanyl 10 mcg in 0.9% Sodium Chloride 1 mL, 1 mL Vial, Concentration: 10 mcg/mL, This is a compounded injectable drug; | Drug | Class II | 10 |
All 4 events for SSM Health Care St. Louis DBA SSM St. Clare Health Center
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Product was distributed in Missouri."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.