November 2020 FDA Recall Doxorubicin Hydrochloride by Fresenius Kabi Usa, Llc
D-0105-2021 - Cross Contamination with Other Products
This Class III drug recall was voluntarily initiated by Fresenius Kabi Usa, Llc on November 17, 2020 for the product Doxorubicin Hydrochloride. The FDA reported the reason for recall as cross contamination with other products. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0105-2021
Cross Contamination with Other Products: trace amounts of octreotide found during testing
11-17-2020
12-02-2020
16,986 vials
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Fresenius Kabi USA, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide USA and Puerto Rico
08-25-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Batch# Batch: 6120525, exp 11/2020
