Why it was recalled
Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
Product description
mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial packaged in a carton, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01.
Lot numbers, UPCs & expiration codes
Lot # 31318659B, Exp 02/17
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-1451-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 31, 2016
- FDA report date
- Aug 3, 2016
- Quantity
- 2,506 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva North America
Original FDA data
Every field from FDA enforcement report D-1451-2016, exactly as published.
Show all FDA fields
- City
- Horsham
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 74514
- Address
- 425 Privet Rd
- Code information
- Lot # 31318659B, Exp 02/17
- Postal code
- 19044-1220
- Report date
- Aug 3, 2016
- Product type
- Drugs
- Recall number
- D-1451-2016
- Classification
- Class III
- Recalling firm
- Teva North America
- Product quantity
- 2,506 vials
- Termination date
- May 8, 2017
- Reason for recall
- Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial packaged in a carton, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01.
- Distribution pattern
- Nationwide
- Recall initiation date
- May 31, 2016
- Initial firm notification
- Letter
- Center classification date
- Jul 28, 2016