Recalls / Class I
Class ID-0765-2022
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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.
- Affected lot / code info
- Lot #: 31329657B, Exp. Date 08/2023
Why it was recalled
Presence of Particulate Matter: Product was found to contain silica and iron oxide
Recalling firm
- Firm
- Teva Pharmaceuticals USA Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy Bldg A, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 1565 vials
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2022-03-29
- FDA classified
- 2022-04-11
- Posted by FDA
- 2022-04-20
- Terminated
- 2023-06-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0765-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.