Product: Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL  33314; Distributed by: Actavis Pharma, Inc., Parsippany, NJ  07054; NDC 0591-2245-22.
Reason for recall: Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
Recall initiated: 20200220
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated