Drug 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.
D-0765-2022
Product summary
- Event
- Event 89876
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1565 vials
- Official record key
drug-enforcement:D-0765-2022
Official wording
Reason: Presence of Particulate Matter: Product was found to contain silica and iron oxide
Code information: Lot #: 31329657B, Exp. Date 08/2023
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter