March 2013 FDA Recall Diclofenac Sodium And Misoprostol by Actavis Inc
D-1060-2014 - Failed Tablet/Capsule Specifications
This Class II drug recall was voluntarily initiated by Actavis Inc on March 22, 2013 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-1060-2014
Failed Tablet/Capsule Specifications: Broken tablets
03-22-2013
02-12-2014
6,540 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Actavis Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
02-26-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60 (60 count bottles)
Batch or Lot Expiration Information
Lot# Lot 668271A, Exp 11/14 and Lot 684119A Exp 01/2015
