PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: December 3, 2014 Initiated: September 26, 2014 #D-0258-2015

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.

Reason for Recall

Failed Tablet/Capsule Specifications: Presence of split or broken tablets.

Details

Units Affected
5,451 Bottles
Distribution
U.S. Nationwide including Puerto Rico.
Location
Davie, FL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Actavis Laboratories, FL, Inc.. Units affected: 5,451 Bottles.
Why was this product recalled?
Failed Tablet/Capsule Specifications: Presence of split or broken tablets.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 3, 2014. Severity: Moderate. Recall number: D-0258-2015.