D-0336-2024 Class II Ongoing
FDA drug recall D-0336-2024 was initiated by Baxter Healthcare Corporation on Jan 23, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 13,000 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 28, 2024
- Initiation Date
- Jan 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,000 bags
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot 23I21G64; Exp. 07/31/2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0336-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026