← FDA ENFORCEMENT
D-0048-2024Class II

Baxter Healthcare Corporation

Recalling firm
Baxter Healthcare Corporation
Product type
Drug
Status
Terminated
Report date
2023-10-25
Distribution
Nationwide in the USA
Firm state
IL
Product quantity
472 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

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

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

Code / lot info

Lot# MKZSU02, Exp 6/30/2024

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.