Reported Feb 19, 2014 · Terminated

Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by:…

Watson Laboratories, Inc.-(Actavis) - Florida

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Watson Laboratories, Inc.-(Actavis) - Florida · 4955 Orange Dr · Davie, FL · 33314-3902

Is this the product you have?

  • Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only
  • Manufactured byWatson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6
Lot codes and dates
    • Lot# 605957A
    • Exp 09/14
Amount recalled
5987 bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 17, 2014 · Data as of Sep 19, 7:17 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.