Norepinephrine Bitartrate in 5% Dextrose Injection recall

Why it was recalled

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.

Details

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

Recalling company

Baxter Healthcare Corporation

Classification

Class II

Status

Ongoing

Type

Voluntary: Firm initiated

Distribution

Nationwide in the USA

Initiated

Jan 23, 2024

FDA report date

Feb 28, 2024