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Recall Observatory FDA recall evidence

Drug 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

D-0336-2024

January 23, 2024

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 93843
Status
Ongoing
Classification
Class II
Quantity
13,000 bags
Official record key
drug-enforcement:D-0336-2024

Official wording

Reason: 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.

Code information: Lot 23I21G64; Exp. 07/31/2024

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.