FDA Drug recall D-0336-2024
Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter H…
- FDA Drug
- Class II
- ongoing
- Published 2024-02-28
On 2024-02-28 the FDA classified a Class II recall of Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter H… by Baxter Healthcare, citing incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly id….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0336-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-23 |
| Published | 2024-02-28 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015. Made in Ireland. NDC: 0338-0108-20
Reason
Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.
Identifiers
| ndc | 0338-0112-20 |
|---|---|
| ndc | 0338-0108-20 |
| ndc | 0338-0116-20 |
| ndc | 0338-0040-20 |
| ndc | 0338-0042-20 |
| ndc | 0338-0128-20 |
| code_info | Lot 23I21G64; Exp. 07/31/2024 |
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-0336-2024%22
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