Norepinephrine Bitartrate Injection, Solution
FDA Recall NDC 0338-0128
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Norepinephrine Bitartrate (NDC 0338-0128). A significant event, classified as Class II, was initiated on Jan 23, 2024 by Baxter Healthcare Corporation. The reported reason for this action was: "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."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
January 2024 Class II Recall: Incorrect product concentration on the overwrap label
Recall Number
Class II Ongoing
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.
Jan 23, 2024
Feb 28, 2024
13,000 bags
Recall Profile & Regulatory Data
Event ID
93843
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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
Batch or Lot Expiration Information
Lot# Lot 23I21G64; Exp. 07/31/2024
Affected Packages Involved in this Recall
0338-0112-20Product
0338-0108-20Product
0338-0116-20Product
0338-0040-20Product
0338-0042-20Product
0338-0128-20Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
