D-1111-2015 Class II Terminated

Recalled by Mylan Lab Inc — Canonsburg, PA

Recall Details

Product Type
Drugs
Report Date
June 10, 2015
Initiation Date
May 20, 2015
Termination Date
October 21, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7,722 bottles

Product Description

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 Pattern

Nationwide

Code Information

Lot #: 3059043, Exp 08/16