FentaNYL citrate recall
FDA recall D-0436-2024 · initiated Feb 29, 2024
SSM Health Care St. Louis DBA SSM St. Clare Health Center recalled FentaNYL citrate in Feb 2024 — an FDA Class II recall (D-0436-2024) because Lack of Assurance of Sterility: Firm did not perform process validation.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility: Firm did not perform process validation.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 140 vials
Details
- Product
- 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
- Recalling company
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- MO
- Initiated
- Feb 29, 2024
- FDA report date
- Apr 10, 2024
Frequently asked
- Was FentaNYL citrate recalled?
- SSM Health Care St. Louis DBA SSM St. Clare Health Center recalled FentaNYL citrate in Feb 2024 — an FDA Class II recall (D-0436-2024) because Lack of Assurance of Sterility: Firm did not perform process validation. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was FentaNYL citrate recalled?
- Per the FDA enforcement record, the reason for recall D-0436-2024 was: Lack of Assurance of Sterility: Firm did not perform process validation.
- Is a recalled FentaNYL citrate dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of FentaNYL citrate are affected?
- Distributed: MO. The recall covers these lots — Lot: 20231031-0C91D9, Exo 29-Feb-2024.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0436-2024.