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FDAJune 30, 2015drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

mylan pharmaceuticalsmylan

UPCs

303782512786

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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. — Recall Details · AllClear