Mylan Pharmaceuticals Inc recalls Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 037…

Recall date

June 30, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1217-2015

FDA classification

Class II

Brand / firm

Mylan Pharmaceuticals Inc

Sold / distributed

Nationwide

Why it was recalled

Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.