Class I · Most seriousRecall completed
IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use
A reasonable chance it could cause serious harm or death.
Does this affect you?
Check your lot numberLot #: 31329657B, Exp. Date 08/2023
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Presence of Particulate Matter: Product was found to contain silica and iron oxide
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
| Distributed by / for | Teva Pharmaceuticals USA Inc |
| NDC | 0703-4154-11 |
Show the full FDA record
| Full product label | 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. |
| Recalling firm | Teva Pharmaceuticals USA Inc |
| Distribution | Nationwide within the United States |
| Quantity | 1565 vials |
| Recall initiated | 2022-03-29 |
| Report date | 2022-04-20 |
| Recall completed | 2023-06-20 |
| Recall number | D-0765-2022 |
| Classification | Class I |
| FDA status | Terminated |
| Origin on file | Parsippany NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.