DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL vial, Sin...
FDA Recall #D-0105-2021 — Class III — November 17, 2020
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
Recalling Firm
Fresenius Kabi USA, LLC — Lake Zurich, IL
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
16,986 vials
Distribution
Nationwide USA and Puerto Rico
Code Information
Batch: 6120525, exp 11/2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated