Bendamustine Hydrochloride Injection
FDA Recall NDC 10019-079
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 Bendamustine Hydrochloride (NDC 10019-079). A significant event, classified as Class III, was initiated on Aug 14, 2023 by Baxter Healthcare Corporation. The reported reason for this action was: "Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial."
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Completed
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
Aug 14, 2023
Aug 30, 2023
13,502 vials
Recall Profile & Regulatory Data
Event ID
92887
Classification
Class III
Enforcement Status
Completed
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S.A.
Product Description
Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 10019-079-01.
Batch or Lot Expiration Information
Lot# Lots: 3A004A, 3A004B, Exp 12/31/2024; 3B005A, Exp 1/31/2025
Affected Packages Involved in this Recall
10019-079-01Product
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.
