Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10 x 10 blister cards, Rx only, Manufactured…

Recall date

September 28, 2016

Source

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

Recall number

D-0136-2017

FDA classification

Class III

Brand / firm

Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Sold / distributed

Nationwide

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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