Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only...
FDA Recall #D-1082-2014 — Class II — December 20, 2013
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.
Recalling Firm
Watson Laboratories, Inc.-(Actavis) - Florida — Davie, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
5987 bottles
Distribution
Nationwide
Code Information
Lot# 605957A, Exp 09/14
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated