Severity
Moderate
ModerateClass IIOngoing
FDA Drug recall · Reported April 10, 2024
FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx Only, Hospital/Office Use Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-9010-1
Lack of Assurance of Sterility: Firm did not perform process validation.
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 FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volu… - a moderate-severity action.
FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volu… was recalled by Ssm Health Care St. Louis DBA Ssm St. Clare Health Center in April 10, 2024. Reason: Lack of Assurance of Sterility: Firm did not perform process validation.. Check the official notice for the remedy. Verify recall #D-0436-2024 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-Lack of Assurance of Sterility: Firm did not perform process validation..
- Moderate
- severity level
- Class II
- classification
- April 10, 2024
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0436-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0436-2024) was formally reported on April 10, 2024, with the manufacturer initiating the action on February 29, 2024. 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 140 vials.
The documented reason for this recall is: Lack of Assurance of Sterility: Firm did not perform process validation. Distribution data in the federal record shows the product reached: MO. 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, 5 from FDA Drug - 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.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications 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
140 vials
Related Recalls
6
5 from same agency
Product description
FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx Only, Hospital/Office Use Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-9010-1
Reason for recall
Lack of Assurance of Sterility: Firm did not perform process validation.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0436-2024 |
| Date reported | April 10, 2024 |
| Date initiated | February 29, 2024 |
| Recalling firm | Ssm Health Care St. Louis DBA Ssm St. Clare Health Center |
| Firm location | Fenton, MO |
| Affected scope | 140 vials |
| Distribution | MO |
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-0436-2024) 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? ▼
FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx Only, Hospital/Office Use Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-9010-1. Recalled by Ssm Health Care St. Louis DBA Ssm St. Clare Health Center. Units affected: 140 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Firm did not perform process validation.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 10, 2024. Severity: Moderate. Recall number: D-0436-2024.
Where was the recalled product distributed? ▼
Distribution: MO.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0436-2024) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3…
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
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 April 10, 2024. 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.