FDA Drug recall D-0444-2023
Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO…
- FDA Drug
- Class II
- terminated
- Published 2023-03-15
On 2023-03-15 the FDA classified a Class II recall of Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO… by Denver Solutions, citing CGMP DEVIATIONS.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0444-2023 |
| 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 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82
Reason
CGMP DEVIATIONS
Identifiers
| code_info | Lot #: 2231017, Exp. Date 3/12/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0444-2023%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.