Diclofenac Sodium And Misoprostol Tablet, Delayed Release
FDA Recall NDC 0591-0397
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 6 recorded enforcement report(s) associated with Diclofenac Sodium And Misoprostol (NDC 0591-0397). A significant event, classified as Class II, was initiated on Sep 26, 2014 by Actavis Pharma, Inc.. The reported reason for this action was: "Failed Tablet/Capsule Specifications: Presence of split or broken tablets."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed Tablet/Capsule Specifications: Presence of split or broken tablets.
Sep 26, 2014
Dec 03, 2014
5,451 Bottles
Recall Profile & Regulatory Data
Event ID
69495
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Actavis Laboratories, FL, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide including Puerto Rico.
Termination Date
Jun 16, 2015
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.
Batch or Lot Expiration Information
Lot# 694320A, Expiry: 02/28/2015.
Affected Packages Involved in this Recall
0591-0397-60Product
0591-0397-19Product
0591-0398-60Product
Class II Terminated
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Apr 24, 2014
Oct 08, 2014
6,041 bottles
Recall Profile & Regulatory Data
Event ID
69237
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Actavis Laboratories, FL, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Dec 23, 2016
Product Description
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
Affected Packages Involved in this Recall
0591-0397-60Product
0591-0397-19Product
0591-0398-60Product
Class II Terminated
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Apr 24, 2014
Oct 08, 2014
36,538 bottles
Recall Profile & Regulatory Data
Event ID
69237
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Actavis Laboratories, FL, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Dec 23, 2016
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.
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
0591-0397-60Product
0591-0397-19Product
0591-0398-60Product
Class II Terminated
Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.
Dec 20, 2013
Feb 19, 2014
5987 bottles
Recall Profile & Regulatory Data
Event ID
67259
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Watson Laboratories, Inc.-(Actavis) - Florida
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 17, 2014
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.
Batch or Lot Expiration Information
Lot# 605957A, Exp 09/14
Affected Packages Involved in this Recall
0591-0397-60Product
0591-0397-19Product
0591-0398-60Product
Class II Terminated
Failed Tablet/Capsule Specifications: Broken tablets
Mar 22, 2013
Feb 12, 2014
6,540 bottles
Recall Profile & Regulatory Data
Event ID
66380
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Actavis Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Feb 26, 2015
Product Description
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
Affected Packages Involved in this Recall
0591-0397-60Product
0591-0397-19Product
0591-0398-60Product
Class II Terminated
Failed Tablet/Capsule Specifications: Broken tablets
Mar 22, 2013
Jul 31, 2013
392,400 tablets
Recall Profile & Regulatory Data
Event ID
65541
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Watson Laboratories, Inc.-(Actavis) - Florida
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 25, 2014
Product Description
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60
Batch or Lot Expiration Information
Lot# Lot 635098A, Exp 10/14
Affected Packages Involved in this Recall
0591-0397-60Product
0591-0397-19Product
0591-0398-60Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
