FDA-Drug2023-10-25Class II

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

Baxter Healthcare Corporation
Hazard

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

Sold states
Nationwide in the USA
Affected count
472 vials
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0048-2024

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