D-0048-2024 Class II Terminated
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