FDASeptember 28, 2016drug

Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10 x 10 blister cards, Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, NDC 51079-882-20

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

The hazard

Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.

What to do

FDA enforcement status: Terminated

Brands named

mylan institutional inc d b a udl laboratoriesmylanmylan institutional

Recall history

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

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