Reported Dec 3, 2014 · Terminated

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

Actavis Laboratories, FL, Inc.

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: Actavis Laboratories, FL, Inc. · 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 # 694320A
  • Expiry02/28/2015
Amount recalled
5,451 Bottles

Where it was sold

  • Nationwide
  • PR

Why it was recalled

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

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 Jun 16, 2015 · Data as of Sep 19, 7:14 PM UTC

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