Doxorubicin Hydrochloride Injection, Solution
FDA Recall NDC 63323-101
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Doxorubicin Hydrochloride (NDC 63323-101). A significant event, classified as Class III, was initiated on Nov 17, 2020 by Fresenius Kabi Usa, Llc. The reported reason for this action was: "Cross Contamination with Other Products: trace amounts of octreotide found during testing"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Cross Contamination with Other Products: trace amounts of octreotide found during testing
Nov 17, 2020
Dec 02, 2020
16,986 vials
Recall Profile & Regulatory Data
Event ID
86765
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA and Puerto Rico
Termination Date
Aug 25, 2022
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
Batch or Lot Expiration Information
Batch# Batch: 6120525, exp 11/2020
Affected Packages Involved in this Recall
63323-883-05Product
63323-883-10Product
63323-883-30Product
63323-101-61Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
