Drug product
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.
D-1451-2016
Product summary
- Event
- Event 74514
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2,506 vials
- Official record key
drug-enforcement:D-1451-2016
Official wording
Reason: Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
Code information: Lot # 31318659B, Exp 02/17
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification