Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV,…

Recall date

January 28, 2016

Source

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

Recall number

D-0650-2016

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 known impurity at 6 month timepoint.

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

What was recalled

Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-881-21