Drug Enforcement D-0048-2024

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

Status

Completed

Classification

Class II

Report Date

October 25, 2023

Termination Date

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Product Information

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
Product quantity
472 vials
Reason for recall
CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Baxter Healthcare Corporation
Address
1 Baxter Pkwy, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0048-2024
Event ID
93201
Recall initiation date
August 24, 2023
Center classification date
October 17, 2023
Code info
Lot# MKZSU02, Exp 6/30/2024
More code info
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