Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV, 26505

Recall Number: D-0506-2019

Firm: Mylan Pharmaceuticals Inc.

Classification: Class III

Status: Terminated

Report Date: 20190227

Initiation Date: 20190213

Termination Date: 20190912

Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing

Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV, 26505