FDA Drug recall D-0279-2024
PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, 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 PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, 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-0279-2024 |
| 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
PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-148-94.
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 #: 2330993, Exp. Date 02/15/2024; 2331010, Exp. Date 02/10/2024; 2331055, Exp. Date 01/18/2024; 2331113, Exp. Date…Lot #: 2330993, Exp. Date 02/15/2024; 2331010, Exp. Date 02/10/2024; 2331055, Exp. Date 01/18/2024; 2331113, Exp. Date 02/26/2024; 2331181, Exp. Date 03/04/2024; 2331187, Exp. Date 03/23/2024; 2331266, Exp. Date 03/31/2024; 2331343, Exp. Date 04/01/2024; 2331349, Exp. Date 04/23/2024; 2331433, Exp. Date 05/05/2024. |
|---|
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-0279-2024%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.