August 2023 FDA Recall Bendamustine Hydrochloride by Baxter Healthcare Corporation
D-1103-2023 - Labeling
This Class III drug recall was voluntarily initiated by Baxter Healthcare Corporation on August 14, 2023 for the product Bendamustine Hydrochloride. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently completed.
Recall Number: D-1103-2023
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
08-14-2023
08-30-2023
13,502 vials
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
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 U.S.A.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
