Reported Feb 18, 2015 · Terminated

Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Pharmaceutical Ind. Ltd…

Sun Pharma Global Fze

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: Sun Pharma Global Fze · Office # 43 Block Y Saif Zone · Sharm, N/A · N/A

Is this the product you have?

  • Levetiracetam, extended release tablets, 750 mg, 60-count bottle, Rx only, Manufactured by Sun Pharmaceutical Ind. Ltd Halol-Baroda Highway, Halol-389 350, Gujarat, India
  • NDC Number47335-576-86
Lot codes and dates
  • Lot #: JKN0249A Exp 02/2016
Amount recalled
3263 bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed Dissolution Specifications: 6 month time point.

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 Oct 23, 2015 · Data as of Sep 19, 7:17 PM UTC

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