Reported Apr 17, 2019 · Terminated

Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot…

Glenmark Pharmaceuticals Inc., USA

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: Glenmark Pharmaceuticals Inc., USA · 750 Corporate Dr · Mahwah, NJ · 07430-2009

Is this the product you have?

  • Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only
  • Manufactured byGlenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma zone SEZ, Pithampur, Dist-Dhar, Madhya Pradesh 454 775, India
  • Manufactured forGlenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. NDC 68462-196-05
Lot codes and dates
  • Lot 17181491 Exp. Aug. 2021
Amount recalled
2076 500-count Bottles

Where it was sold

  • Nationwide

Why it was recalled

Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.

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 14, 2020 · Data as of Sep 19, 7:23 PM UTC

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