Class II
Ongoing
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
This recall is currently active, issued February 28, 2024. It was issued by Baxter Healthcare Corporation.
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- January 23, 2024
- Posted
- February 28, 2024
- Recall Number
- D-0336-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 13,000 bags
- Firm Location
- Deerfield, IL, United States
- Official Source
- View on FDA website ↗
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
Nationwide in the USA
Lot / Code Info
Lot 23I21G64; Exp. 07/31/2024
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