FDA Drug recall D-0277-2024
FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only
- FDA Drug
- Class I
- ongoing
- Published 2024-02-07
On 2024-02-07 the FDA classified a Class I recall of FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only by Denver Solutions, citing superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0277-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-12-28 |
| Published | 2024-02-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Denver Solutions |
| Distribution | US |
Product
FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-41.
Reason
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Identifiers
| code_info | Lot #: 2331062, Exp. Date: 02/08/2024; 2331224, Exp. Date 03/18/2024; 2331270, Exp. Date 03/28/2024. |
|---|
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-0277-2024%22
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