D-0730-2021 Class II Terminated

Recalled by Teva Pharmaceuticals USA — Parsippany, NJ

Recall Details

Product Type
Drugs
Report Date
August 25, 2021
Initiation Date
July 29, 2021
Termination Date
June 4, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,351 vials

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

Distribution Pattern

Product was distributed Nationwide, including Puerto Rico.

Code Information

Lot #: 31329250B, exp. date 08/2022