FDA-Drug2016-08-03Class III
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.
Teva North America
Hazard
Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
Sold states
Nationwide
Affected count
2,506 vials
Manufactured in
425 Privet Rd, N/A, Horsham, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1451-2016Don't want to check this manually?
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