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.

Recall Number: D-1111-2015

Firm: Mylan Lab Inc

Classification: Class II

Status: Terminated

Report Date: 20150610

Initiation Date: 20150520

Termination Date: 20161021

Failed Dissolution Specifications: Low out of specification dissolution results.

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.