Why it was recalled
Presence of Particulate Matter: Product was found to contain silica and iron oxide
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.
Lot numbers, UPCs & expiration codes
Lot #: 31329657B, Exp. Date 08/2023
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0765-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 29, 2022
- FDA report date
- Apr 20, 2022
- Quantity
- 1565 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA Inc
Original FDA data
Every field from FDA enforcement report D-0765-2022, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 89876
- Address
- 400 Interpace Pkwy Bldg A
- Code information
- Lot #: 31329657B, Exp. Date 08/2023
- Postal code
- 07054-1120
- Report date
- Apr 20, 2022
- Product type
- Drugs
- Recall number
- D-0765-2022
- Classification
- Class I
- Recalling firm
- Teva Pharmaceuticals USA Inc
- Product quantity
- 1565 vials
- Termination date
- Jun 20, 2023
- Reason for recall
- Presence of Particulate Matter: Product was found to contain silica and iron oxide
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Mar 29, 2022
- Initial firm notification
- Letter
- Center classification date
- Apr 11, 2022