Product: Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA; NDC 66993-485-32.
Reason for recall: Failed Dissolution Specifications: Out of specification result for dissolution.
Recall initiated: 20190531
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated