PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: October 8, 2014 Initiated: April 24, 2014 #D-1617-2014

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.

Reason for Recall

Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.

Details

Units Affected
6,041 bottles
Distribution
Nationwide and Puerto Rico
Location
Davie, FL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Actavis Laboratories, FL, Inc.. Units affected: 6,041 bottles.
Why was this product recalled?
Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 8, 2014. Severity: Moderate. Recall number: D-1617-2014.