Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6.

Recall Number: D-1082-2014

Firm: Watson Laboratories, Inc.-(Actavis) - Florida

Classification: Class II

Status: Terminated

Report Date: 20140219

Initiation Date: 20131220

Termination Date: 20140917

Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.

Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6.