Mylan Pharmaceuticals Inc recalls Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378
Recalled July 15, 2015 · FDA recall D-1217-2015 · Mylan Pharmaceuticals
Hazard
Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point. · FDA Class II
Units
1068 bottles
Sold at
Nationwide
Description
Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.
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.
Manufacturer(s)
Mylan Pharmaceuticals Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →