Class III
Terminated
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.
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- September 13, 2016
- Posted
- October 19, 2016
- Recall Number
- D-0095-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 11,214 vials
- Firm Location
- North Wales, PA, United States
Reason for Recall
Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
Distribution
Nationwide
Lot / Code Info
Lot Numbers: 31318574B, Exp 09/16; 31319610B, Exp 07/17; 31320058B, Exp 11/17; 31320497B, Exp 12/17; 31320744B, Exp 02/18
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