Reported May 30, 2018 · Terminated

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

Exela Pharma Sciences LLC

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: Exela Pharma Sciences LLC · 1245 Blowing Rock Blvd · Lenoir, NC · 28645-3618

Is this the product you have?

  • Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only
  • Manufactured byCipla Ltd., India
  • ForEAGLE PHARMACEUTICALS, INC., Woodcliff Lake, NJ 07677 USA, NDC 42367-111-06
Lot codes and dates
  • Lot
    • GH70154
    • Exp 12/18
Amount recalled
5256 bottles

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg 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 4, 2020 · Data as of Sep 19, 5:02 PM UTC

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