Product: Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin Limited, Nagpur-441108, India, NDC 68180-169-16
Reason for recall: Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Recall initiated: 20220610
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated