FDA recall D-0650-2016

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

Product

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

Reason for recall

Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2016-01-28
Report date
2016-02-10
Termination date
2016-12-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Rockford, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0650-2016