Reported Jul 31, 2013 · Terminated

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

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, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60
Lot codes and dates
    • Lot 635098A
    • Exp 10/14
Amount recalled
392,400 tablets

Where it was sold

  • Nationwide

Why it was recalled

Failed Tablet/Capsule Specifications: 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 Sep 25, 2014 · Data as of Sep 19, 5:54 PM UTC

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