FDA recall D-0135-2017

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) · Class III · drug

Product

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2016-09-28
Report date: 2016-11-16
Termination date: 2018-08-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Rockford, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0135-2017