Glenmark Mometasone Furoate Cream Recalled for Gritty Texture
Glenmark Pharmaceuticals is recalling Mometasone Furoate Cream due to market complaints about a gritty texture.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a quality deviation (gritty texture) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Glenmark Pharmaceuticals Inc. is recalling Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g. The recall was initiated due to market complaints regarding a gritty texture in the product.
The affected product is identified by Batch Number 05170598 and has an expiration date of 03/19. A total of 5,136 tubes were distributed throughout the United States.
Consumers with this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- 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
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Topical Steroid
- Hazard
- Affected units
- 5,136
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch Number: 05170598
- Exp. 03/19
Distribution
Distribution scope not specified by the agency.
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