FDA-Drug2016-10-19Class III
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.
Teva Pharmaceuticals USA
Hazard
Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
Sold states
Nationwide
Affected count
11,214 vials
Manufactured in
1090 Horsham Rd, N/A, North Wales, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0095-2017Don't want to check this manually?
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