September 2014 FDA Recall Diclofenac Sodium And Misoprostol by Actavis Laboratories, Fl, Inc.
D-0258-2015 - Failed Tablet/Capsule Specifications

This Class II drug recall was voluntarily initiated by Actavis Laboratories, Fl, Inc. on September 26, 2014 for the product Diclofenac Sodium And Misoprostol. The FDA reported the reason for recall as failed tablet/capsule specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0258-2015

Reason for Recall
Failed Tablet/Capsule Specifications: Presence of split or broken tablets.
Initiated
09-26-2014
Reported
12-03-2014
Quantity
5,451 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69495
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Actavis Laboratories, FL, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2015
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# 694320A, Expiry: 02/28/2015.

Affected Packages Involved in this Recall

0591-0397-60 Diclofenac Sodium And Misoprostol
0591-0397-19 Diclofenac Sodium And Misoprostol
0591-0398-60 Diclofenac Sodium And Misoprostol