PlainRecalls
FDA Drug Moderate Class II Terminated

DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618 Vial NDC# 0703-5233-11, Carton NDC # 0703-5233-13

Reported: August 25, 2021 Initiated: July 29, 2021 #D-0730-2021

Product Description

DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618 Vial NDC# 0703-5233-11, Carton NDC # 0703-5233-13

Reason for Recall

Lack of Assurance of Sterility

Details

Recalling Firm
Teva Pharmaceuticals USA
Units Affected
1,351 vials
Distribution
Product was distributed Nationwide, including Puerto Rico.
Location
Parsippany, NJ

Frequently Asked Questions

What product was recalled?
DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618 Vial NDC# 0703-5233-11, Carton NDC # 0703-5233-13. Recalled by Teva Pharmaceuticals USA. Units affected: 1,351 vials.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on August 25, 2021. Severity: Moderate. Recall number: D-0730-2021.