Recall: D-0105-2021

Class III - Minor Violations

Class IIIClassification

2020-11-17Initiated

TerminatedStatus

Fresenius Kabi USA, LLCFirm

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

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

Distribution

Nationwide USA and Puerto Rico

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.