Drug product
Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2512-78, UPC 3 0378-2512-78 6.
D-1217-2015
Product summary
- Event
- Event 71566
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1068 bottles
- Official record key
drug-enforcement:D-1217-2015
Official wording
Reason: Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.
Code information: Lot #: 3053562, Exp 02/16
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out-of-specification