January 2024 FDA Recall Norepinephrine Bitartrate by Baxter Healthcare Corporation
D-0336-2024 - Incorrect product concentration on the overwrap label
This Class II drug recall was voluntarily initiated by Baxter Healthcare Corporation on January 23, 2024 for the product Norepinephrine Bitartrate. The FDA reported the reason for recall as incorrect product concentration on the overwrap label. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0336-2024
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.
01-23-2024
02-28-2024
13,000 bags
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Baxter Healthcare Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# Lot 23I21G64; Exp. 07/31/2024
