Drug 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
D-0048-2024
Product summary
- Event
- Event 93201
- Status
- Terminated
- Classification
- Class II
- Quantity
- 472 vials
- Official record key
drug-enforcement:D-0048-2024
Official wording
Reason: CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Code information: Lot# MKZSU02, Exp 6/30/2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations