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Recall Observatory FDA recall evidence

Drug product

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

D-0048-2024

August 24, 2023

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 93201
Status
Terminated
Classification
Class II
Quantity
472 vials
Official record key
drug-enforcement:D-0048-2024

Official wording

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

Code information: Lot# MKZSU02, Exp 6/30/2024

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations