FDA Recall D-0765-2022
Teva Pharmaceuticals USA Inc · Parsippany, NJ
Class I — life-threatening Terminated 448 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Recall record
- Recall number
D-0765-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide within the United States
- Recall initiated
- 2022-03-29
- Classified by FDA Center
- 2022-04-11
- FDA published
- 2022-04-20
- Terminated
- 2023-06-20
- Recalling firm
- Teva Pharmaceuticals USA Inc
- Firm location
- Parsippany, NJ