Drug product
Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Teva Czech Industries sro, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7474-89
D-0732-2016
Product summary
- Event
- Event 72912
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,895 bottles
- Official record key
drug-enforcement:D-0732-2016
Official wording
Reason: Failed Dissolution Specifications: low test results at the 18 month time-point
Code information: Lot # 3A404012V, Exp. 4/2016
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications