PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: October 25, 2023 Initiated: August 24, 2023 #D-0048-2024

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.

Details

Units Affected
472 vials
Distribution
Nationwide in the USA
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Baxter Healthcare Corporation. Units affected: 472 vials.
Why was this product recalled?
CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 25, 2023. Severity: Moderate. Recall number: D-0048-2024.