mitoXANTRONE Injection (Teva) – Impurities Specification Failure (2016)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Teva Pharmaceuticals USA
Lot Codes / Batch Numbers
Lot Numbers: 31318574B, Exp 09/16, 31319610B, Exp 07/17, 31320058B, Exp 11/17, 31320497B, Exp 12/17, 31320744B, Exp 02/18
Products Sold
Lot Numbers: 31318574B, Exp 09/16; 31319610B, Exp 07/17; 31320058B, Exp 11/17; 31320497B, Exp 12/17; 31320744B, Exp 02/18
Teva Pharmaceuticals USA is recalling mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial, Rx only, due to Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026