Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactur...
FDA Recall #D-1103-2023 — Class III — August 14, 2023
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.
Reason for Recall
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
Recalling Firm
Baxter Healthcare Corporation — Deerfield, IL
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
13,502 vials
Distribution
Nationwide in the U.S.A.
Code Information
Lots: 3A004A, 3A004B, Exp 12/31/2024; 3B005A, Exp 1/31/2025
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated