D-0048-2024 Class II Terminated

Recalled by Baxter Healthcare Corporation — Deerfield, IL

Recall Details

Product Type
Drugs
Report Date
October 25, 2023
Initiation Date
August 24, 2023
Termination Date
December 22, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
472 vials

Product Description

Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC 0338-0067-01

Reason for Recall

CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.

Distribution Pattern

Nationwide in the USA

Code Information

Lot# MKZSU02, Exp 6/30/2024