FDA Drug Class III — Least Serious

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

Hazard

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

Products

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
Brand
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
UPC
Lot#: 3061784, Exp 11/16; 3067656, Exp 12/16; 3074902, Exp 08/17

Units Affected

46,472 unit dose blister cards (10 cards of 10 tablets each)