FDA recall D-0105-2021

Product

DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL vial, Single Dose Vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047. NDC: 63323-883-05

Reason for recall

Cross Contamination with Other Products: trace amounts of octreotide found during testing

Distribution

Nationwide USA and Puerto Rico

Key facts

Status

Terminated

Initiation date

2020-11-17

Report date

2020-12-02

Termination date

2022-08-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Zurich, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0105-2021