Severity
Moderate
ModerateClass IIOngoing
FDA Drug recall · Reported June 7, 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
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are pu…
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Ssm Health Care St. Louis DBA Ssm St. Clare Health Center recalled HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM… - a moderate-severity action.
HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM… was recalled by Ssm Health Care St. Louis DBA Ssm St. Clare Health Center in June 7, 2023. Reason: CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the id…. Check the official notice for the remedy. Verify recall #D-0776-2023 with the FDA Drug before acting.
The recall
Ssm Health Care St. Louis DBA Ssm St. Clare Health Center issued this moderate-severity FDA Drug recall-CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the id….
- Moderate
- severity level
- Class II
- classification
- June 7, 2023
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0776-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0776-2023) was formally reported on June 7, 2023, with the manufacturer initiating the action on May 9, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Ssm Health Care St. Louis DBA Ssm St. Clare Health Center is listed as the recalling firm, operating out of Fenton, MO. Federal records list the affected scope as 3,232 syringes.
The documented reason for this recall is: 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 data in the federal record shows the product reached: Product was distributed in Missouri.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
3,232 syringes
Related Recalls
6
0 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0776-2023 |
| Date reported | June 7, 2023 |
| Date initiated | May 9, 2023 |
| Recalling firm | Ssm Health Care St. Louis DBA Ssm St. Clare Health Center |
| Firm location | Fenton, MO |
| Affected scope | 3,232 syringes |
| Distribution | Product was distributed in Missouri. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0776-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Ssm Health Care St. Louis DBA Ssm St. Clare Health Center. Units affected: 3,232 syringes.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 7, 2023. Severity: Moderate. Recall number: D-0776-2023.
Where was the recalled product distributed? ▼
Distribution: Product was distributed in Missouri..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0776-2023) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported June 7, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.