FDA recall D-0378-2015

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

Product

LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 blister cards per carton), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-866-20

Reason for recall

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices

Distribution

Nationwide and Puerto Rico.

Key facts

Status: Terminated
Initiation date: 2013-09-26
Report date: 2015-01-28
Termination date: 2015-11-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Rockford, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0378-2015