Recalls / Class II
Class IID-0048-2024
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
- Brand name
- Doxil
- Generic name
- Doxorubicin Hydrochloride
- Active ingredient
- Doxorubicin Hydrochloride
- Route
- Intravenous
- NDCs
- 0338-0063, 0338-0067
- FDA application
- NDA050718
- Affected lot / code info
- Lot# MKZSU02, Exp 6/30/2024
Why it was recalled
CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Manufacturer
- Baxter Healthcare Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, N/A, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 472 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-08-24
- FDA classified
- 2023-10-17
- Posted by FDA
- 2023-10-25
- Terminated
- 2025-12-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0048-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.