Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA; NDC 66993-485-32.
Recall Number: D-1342-2019
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
Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA; NDC 66993-485-32.