FDA recall D-0765-2022

Product

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

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2022-03-29

Report date

2022-04-20

Termination date

2023-06-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0765-2022