Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: Market complaints related to "gritty texture".
Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: Glenmark Pharmaceuticals Ltd. Village Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 NDC 68462019255 UPC 3684620192559
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Defective Delivery System: The dip tube is clogged causing the spray not to work.
Reason Defective Container
Reason Defective Container
Reason Defective Container
Reason Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9…
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