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.

FDA recall notice · announced August 3, 2016 · Teva

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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.

Notes

Distribution: Nationwide
Lot/code information: Lot # 31318659B, Exp 02/17
Quantity: 2,506 vials
Status: Terminated
Products in this recall event:
- 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. (D-1451-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.