mitoXANTRONE Injection USP recall: Impurity Out of Spec
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.
Why was mitoXANTRONE Injection USP recalled?
Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 31318659B, Exp 02/17
- 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.
- Recalling firm
- Teva North America
- Quantity
- 2,506 vials
- Distribution
- Nationwide
- Recall date
- August 3, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)