Product: 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
Reason for recall: Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing
Recall initiated: 20190213
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated