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.
Recall Number: D-1341-2019
Firm: Chiesi USA, Inc.
Classification: Class II
Status: Terminated
Report Date: 20190619
Initiation Date: 20190531
Termination Date: 20210308
Reason for Recall
Failed Dissolution Specifications: Out of specification result for dissolution.
Product Description
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.