FDA Drug Class III — Least Serious

Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x 10 blister cards (NDC 51079-881-20) and b) 300-count unit dose box of 10 x 30 punch cards (NDC 51079-881-56), Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505

Hazard

Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.

Products

Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x 10 blister cards (NDC 51079-881-20) and b) 300-count unit dose box of 10 x 30 punch cards (NDC 51079-881-56), Rx only,
Brand
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
UPC
Lot#: a) 3061779, Exp 11/16; 3071447, Exp 04/17; b)3071789, Exp 04/17

Units Affected

1,182 unit dose cards of 300 (10 punch cards of 30 tablets each) and 52,618 unit dose blister cards (10 cards of 10 tablets each)