Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05.
Recall Number: D-1557-2014
Firm: Mylan Pharmaceuticals Inc.
Classification: Class III
Status: Terminated
Report Date: 20140903
Initiation Date: 20140619
Termination Date: 20150723
Reason for Recall
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Product Description
Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05.