Product: ZYFLO CR (zileuton) extended-release tablets, 600 mg, 120-count bottles, Rx only, Distributed by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-902-12.
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