Reported Oct 19, 2016 · Terminated
mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial, Rx only, Teva Parenteral…
Teva Pharmaceuticals USA
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA · 1090 Horsham Rd · North Wales, PA · 19454-1505
Is this the product you have?
- 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.
- Lot codes and dates
- Lot Numbers
31318574BExp 09/1631319610BExp 07/1731320058BExp 11/1731320497BExp 12/1731320744BExp 02/18
- Lot Numbers
- Amount recalled
- 11,214 vials
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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