FDA recall D-1111-2015

Mylan Lab Inc · Class II · drug

Product

Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-4201-78, UPC 3 0378-4201-78 7.

Reason for recall

Failed Dissolution Specifications: Low out of specification dissolution results.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2015-05-20
Report date: 2015-06-10
Termination date: 2016-10-21
Voluntary/Mandated: Voluntary: Firm initiated
Location: Canonsburg, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1111-2015