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)

FDA recall notice · announced February 12, 2014 · Actavis

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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)

Reason for recall

Failed Tablet/Capsule Specifications: Broken tablets

Notes

Distribution: Nationwide
Lot/code information: Lot 668271A, Exp 11/14 and Lot 684119A Exp 01/2015
Quantity: 6,540 bottles
Status: Terminated
Products in this recall event:
- 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) (D-1060-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.