Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01

Recall Number: D-1186-2018

Firm: Mylan Pharmaceuticals Inc.

Classification: Class III

Status: Terminated

Report Date: 20180919

Initiation Date: 20180807

Termination Date: 20190814

Reason for Recall

Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.

Product Description

Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01