Norepinephrine Bitartrate in 5% Dextrose Injection — Class II drug recall D-0336-2024
Ongoing recall by Baxter Healthcare Corporation, reported 2024-02-28, distributed nationwide. Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product s
| Recall number | D-0336-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2024-01-23 |
| Classified | 2024-02-16 |
| Reported by FDA | 2024-02-28 |
| Distributed | Nationwide (US) |
| Quantity | 13,000 bags |
| Reason classes | labeling, potency |
| NDC | 00338-0040, 00338-0040-20, 00338-0042, 00338-0042-20, 00338-0108, 00338-0108-20, 00338-0112, 00338-0112-20, 00338-0116, 00338-0116-20, 00338-0128, 00338-0128-20 |
| Lot numbers | 23I21G64 |
| Expiration dates | 2024-07-31 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0336-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.