FDA Drug recall D-0282-2024
VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, 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 VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, 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-0282-2024 |
| 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
VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-029-68.
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 #: 2331140, Exp. Date 02/08/2024; 2331188, Exp. Date 02/15/2024; 2331261, Exp. Date 03/05/2024; 2331287, Exp. Date 03/14/2024. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Denver Solutions
- PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Bl…
FDA Drug · Class II · 2025-04-30 · Denver Solutions - dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters He…
FDA Drug · Class II · 2025-04-30 · Denver Solutions - Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112
FDA Drug · Class II · 2025-04-30 · Denver Solutions - Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112
FDA Drug · Class II · 2025-04-30 · Denver Solutions - Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71…
FDA Drug · Class II · 2025-04-30 · Denver Solutions
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0282-2024%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.