Class III
Terminated
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.
This recall has been terminated (originally issued August 3, 2016).
- Company
- Teva North America
- Recall Initiated
- May 31, 2016
- Posted
- August 3, 2016
- Recall Number
- D-1451-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2,506 vials
- Firm Location
- Horsham, PA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
Distribution
Nationwide
Lot / Code Info
Lot # 31318659B, Exp 02/17
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