Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Inf...
FDA Recall #D-0336-2024 — Class II — January 23, 2024
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.
Recalling Firm
Baxter Healthcare Corporation — Deerfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
13,000 bags
Distribution
Nationwide in the USA
Code Information
Lot 23I21G64; Exp. 07/31/2024
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated