FDA Drug recall D-0442-2023
Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11
- FDA Drug
- Class II
- terminated
- Published 2023-03-15
On 2023-03-15 the FDA classified a Class II recall of Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11 by Denver Solutions, citing CGMP DEVIATIONS.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0442-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-02-21 |
| Published | 2023-03-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Denver Solutions |
| Distribution | US |
Product
Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11
Reason
CGMP DEVIATIONS
Identifiers
| code_info | Lot #: 2230960, Exp date 3/12/2023; 2231080, Exp date 4/9/2023. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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-0442-2023%22
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