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.
Reported: August 3, 2016 Initiated: May 31, 2016 #D-1451-2016
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.
Reason for Recall
Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
Details
- Recalling Firm
- Teva North America
- Units Affected
- 2,506 vials
- Distribution
- Nationwide
- Location
- Horsham, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Teva North America. Units affected: 2,506 vials.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 3, 2016. Severity: Low. Recall number: D-1451-2016.
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