FDA-Drug2015-07-15Class II
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.
Mylan Pharmaceuticals Inc
Hazard
Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.
Sold states
Nationwide
Affected count
1068 bottles
Manufactured in
781 Chestnut Ridge Rd, N/A, Morgantown, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1217-2015Don't want to check this manually?
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