D-0765-2022 Class I Terminated
FDA drug recall D-0765-2022 was initiated by Teva Pharmaceuticals USA Inc on Mar 29, 2022 and is designated Class I. Reason for recall: Presence of Particulate Matter: Product was found to contain silica and iron oxide The recall status is terminated (terminated Jun 20, 2023). Affected quantity: 1565 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 20, 2022
- Initiation Date
- Mar 29, 2022
- Termination Date
- Jun 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0765-2022
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026