D-0765-2022 Class I Terminated

Recalled by Teva Pharmaceuticals USA Inc — Parsippany, NJ

Recall Details

Product Type
Drugs
Report Date
April 20, 2022
Initiation Date
March 29, 2022
Termination Date
June 20, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1565 vials

Product Description

IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmaceuticals, USA, Inc., North Wales, PA 19454, NDC 0703-4154-11.

Reason for Recall

Presence of Particulate Matter: Product was found to contain silica and iron oxide

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 31329657B, Exp. Date 08/2023