FDA Drug recall D-0436-2024
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…
- FDA Drug
- Class II
- ongoing
- Published 2024-04-10
On 2024-04-10 the FDA classified a Class II recall of 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… by Ssm Health Care St Louis, citing lack of Assurance of Sterility: Firm did not perform process validation.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0436-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-29 |
| Published | 2024-04-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ssm Health Care St Louis |
| Distribution | MO |
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
Reason
Lack of Assurance of Sterility: Firm did not perform process validation.
Identifiers
| code_info | Lot: 20231031-0C91D9, Exo 29-Feb-2024. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0436-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.