Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08

Recall Number: D-1112-2018

Firm: Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Classification: Class III

Status: Terminated

Report Date: 20180829

Initiation Date: 20180814

Termination Date: 20200626

Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer

Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08