Reported Aug 14, 2019 · Terminated
Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-192-17) and b) 45 gram tubes (NDC…
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?
- Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-192-17) and b) 45 gram tubes (NDC 68462-192-55), Rx Only, Manufactured by
- Glenmark Pharmaceuticals Ltd AtVillage: Kishanpura, Baddi Nalagari Road
- DistrictSolan, Himachal Pradesh -173205, India Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
- Lot codes and dates
142 of 142 codes
a) 051712380517124805171249Exp. Jul-20190517158205171612Exp. Aug-2019051716740517167505171682Exp. Sep 20190518006505180066Exp. Dec 2019051802640518026405180265051802750518276Exp. Jan 2020051804110518041205180422Exp. Jan 20200518055605180568 Exp..Feb-20200518088905180890051808960518089605180897 Exp. Apr 202005181123051811290518113405181135Exp. May 202005181415051814250518142905181433Exp. Jun 202005181528Exp. Jul 20200518174705181748Exp. Aug 2020. b) 0517120705171212051712130517123205171233Exp. Jul-2019051714760517147805171479Exp. Aug 201905171596051715970517160205171603Exp. Aug 2019
- Amount recalled
- N/A
Where it was sold
- Nationwide
Why it was recalled
GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty.
This product could cause temporary or reversible health problems — stop using it.
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