Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA

Recall Number: D-0151-2017

Firm: Mylan Pharmaceuticals Inc.

Classification: Class III

Status: Terminated

Report Date: 20161130

Initiation Date: 20161103

Termination Date: 20170801

Failed Impurities/Degradation Specifications: OOS results for known compound.

Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA