PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: December 2, 2020 Initiated: November 17, 2020 #D-0105-2021

Product Description

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

Details

Recalling Firm
Fresenius Kabi USA, LLC
Units Affected
16,986 vials
Distribution
Nationwide USA and Puerto Rico
Location
Lake Zurich, IL

Frequently Asked Questions

What product was recalled?
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. Recalled by Fresenius Kabi USA, LLC. Units affected: 16,986 vials.
Why was this product recalled?
Cross Contamination with Other Products: trace amounts of octreotide found during testing
Which agency issued this recall?
This recall was issued by the FDA Drug on December 2, 2020. Severity: Low. Recall number: D-0105-2021.