mitoXANTRONE Injection USP recall: Impurity Out of Spec
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…
Why was mitoXANTRONE Injection USP recalled?
Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
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 Numbers: 31318574B, Exp 09/16; 31319610B, Exp 07/17; 31320058B, Exp 11/17; 31320497B, Exp 12/17; 31320744B, Exp 02/18
- 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…
- Recalling firm
- Teva Pharmaceuticals USA
- Quantity
- 11,214 vials
- Distribution
- Nationwide
- Recall date
- October 19, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)