Why it was recalled
Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
Product description
mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01.
Lot numbers, UPCs & expiration codes
Lot Numbers: 31318574B, Exp 09/16; 31319610B, Exp 07/17; 31320058B, Exp 11/17; 31320497B, Exp 12/17; 31320744B, Exp 02/18
Where it was sold
Nationwide
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-0095-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 13, 2016
- FDA report date
- Oct 19, 2016
- Quantity
- 11,214 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0095-2017, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 75236
- Address
- 1090 Horsham Rd
- Code information
- Lot Numbers: 31318574B, Exp 09/16; 31319610B, Exp 07/17; 31320058B, Exp 11/17; 31320497B, Exp 12/17; 31320744B, Exp 02/18
- Postal code
- 19454-1505
- Report date
- Oct 19, 2016
- Product type
- Drugs
- Recall number
- D-0095-2017
- Classification
- Class III
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 11,214 vials
- Termination date
- May 5, 2017
- Reason for recall
- Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01.
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 13, 2016
- Initial firm notification
- Letter
- Center classification date
- Oct 12, 2016