Multi-event April 2014 FDA Recall Diclofenac Sodium And Misoprostol by Actavis Laboratories, Fl, Inc.
This Multi-event Class II drug recall was voluntarily initiated by Actavis Laboratories, Fl, Inc. on April 24, 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.
Reported Recall Events
Recall Number: D-1616-2014
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
04-24-2014
10-08-2014
36,538 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 Laboratories, FL, 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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico
12-23-2016
Product Description About Product Description
Full technical description of the product.
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# : 605956A, 605958A, Exp. 9/30/2014; 644678M, Exp. 10/31/2014; 661841A, Exp. 11/30/2014; 717469A, Exp 2/28/2015
Affected Packages Involved in this Recall
Recall Number: D-1617-2014
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
04-24-2014
10-08-2014
6,041 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 Laboratories, FL, 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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico
12-23-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0397-60, UPC 3 05910 39760 9.
Batch or Lot Expiration Information
Lot# : 660513A, Exp. 10/31/2014
