D-1082-2014 Class II Terminated

Recalled by Watson Laboratories, Inc.-(Actavis) - Florida — Davie, FL

Recall Details

Product Type
Drugs
Report Date
February 19, 2014
Initiation Date
December 20, 2013
Termination Date
September 17, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5987 bottles

Product Description

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.

Reason for Recall

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

Distribution Pattern

Nationwide

Code Information

Lot# 605957A, Exp 09/14