D-0048-2024 Class II Terminated
FDA drug recall D-0048-2024 was initiated by Baxter Healthcare Corporation on Aug 24, 2023 and is designated Class II. Reason for recall: CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake. The recall status is terminated (terminated Dec 22, 2025). Affected quantity: 472 vials.
Recall details
- Product Type
- Drugs
- Report Date
- Oct 25, 2023
- Initiation Date
- Aug 24, 2023
- Termination Date
- Dec 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0048-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026