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.

Recall Number: D-0862-2020

Firm: Teva Pharmaceuticals USA

Classification: Class II

Status: Terminated

Report Date: 20200311

Initiation Date: 20200220

Termination Date: 20201006

Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.

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.