Doxil Injection, Suspension, Liposomal
FDA Recall NDC 0338-0063
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Doxil (NDC 0338-0063). A significant event, classified as Class II, was initiated on Aug 24, 2023 by Baxter Healthcare Company. The reported reason for this action was: "CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Aug 24, 2023
Oct 25, 2023
472 vials
Recall Profile & Regulatory Data
Event ID
93201
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Dec 22, 2025
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
Batch or Lot Expiration Information
Lot# MKZSU02, Exp 6/30/2024
Affected Packages Involved in this Recall
0338-0063-01Product
0338-0067-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
