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.
Reported: October 19, 2016 Initiated: September 13, 2016 #D-0095-2017
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.
Reason for Recall
Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 11,214 vials
- Distribution
- Nationwide
- Location
- North Wales, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Teva Pharmaceuticals USA. Units affected: 11,214 vials.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 19, 2016. Severity: Low. Recall number: D-0095-2017.
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