Recalls / Class III
Class IIID-1451-2016
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.
- Affected lot / code info
- Lot # 31318659B, Exp 02/17
Why it was recalled
Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
Recalling firm
- Firm
- Teva North America
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 425 Privet Rd, N/A, Horsham, Pennsylvania 19044-1220
Distribution
- Quantity
- 2,506 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-05-31
- FDA classified
- 2016-07-28
- Posted by FDA
- 2016-08-03
- Terminated
- 2017-05-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1451-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.