FDA-Drug2022-04-20Class I

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.

Teva Pharmaceuticals USA Inc
Hazard

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

Sold states
Nationwide within the United States
Affected count
1565 vials
Manufactured in
400 Interpace Pkwy Bldg A, N/A, Parsippany, NJ, United States
Products
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.

Official notice

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

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