Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.
Recall Number: D-1435-2014
Firm: Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Classification: Class III
Status: Terminated
Report Date: 20140723
Initiation Date: 20140703
Termination Date: 20160726
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, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.