Recalls / Class III
Class IIID-0095-2017
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.
- Affected lot / code info
- Lot Numbers: 31318574B, Exp 09/16; 31319610B, Exp 07/17; 31320058B, Exp 11/17; 31320497B, Exp 12/17; 31320744B, Exp 02/18
Why it was recalled
Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, N/A, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 11,214 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-09-13
- FDA classified
- 2016-10-12
- Posted by FDA
- 2016-10-19
- Terminated
- 2017-05-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0095-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.