Product: Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per 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: Out-of-specification dissolution results were obtained during stability testing.
Recall initiated: 20201028
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated