FDAFDA · Food and drugs·Recall number D-0336-2018
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
Published February 7, 2018 · Recall initiated: November 20, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Market complaints related to "gritty texture".
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Distributor
- Product was distributed throughout the United States.
- Lot
- Batch Number: 05170598; Exp. 03/19
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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