Reported Feb 7, 2018 · Terminated

Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: Glenmark Pharmaceuticals Ltd. Village…

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?

  • Glenmark Mometasone Furoate Cream, USP, 0.1%, 45
  • g Rx Only Manufactured byGlenmark Pharmaceuticals Ltd
  • Village Manufactured forGlenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 NDC 68462019255 UPC 3684620192559
Lot codes and dates
  • Batch Number
    • 05170598
    • Exp. 03/19
Amount recalled
5136 tubes

Why it was recalled

CGMP Deviations: Market complaints related to "gritty texture".

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 3, 2018 · Data as of Sep 19, 5:01 PM UTC

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