FDA Drug Class II — Moderate

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.

Hazard

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

Products

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.
Brand
Actavis Laboratories, FL, Inc.
UPC
Lot #: 660513A, Exp. 10/31/2014

Units Affected

6,041 bottles