FDA recall D-0136-2017

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

Product

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

Reason for recall

Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 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-0136-2017