Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-5445-91.
Recall Number: D-1539-2014
Firm: Mylan Pharmaceuticals Inc.
Classification: Class III
Status: Terminated
Report Date: 20140827
Initiation Date: 20140620
Termination Date: 20151009
Reason for Recall
Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.
Product Description
Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-5445-91.