# FDA recall D-0336-2018

> **Glenmark Pharmaceuticals Inc., USA** · Class II · drug recall initiated 2017-11-20.

## 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

## Reason for recall

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

## Distribution

Product was distributed throughout the United States.

## Key facts

- **Recall number:** D-0336-2018
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-11-20
- **Report date:** 2018-02-07
- **Termination date:** 2018-10-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mahwah, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0336-2018

## Citation

> AI Analytics. FDA recall D-0336-2018. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-0336-2018. Source: US FDA. Licensed CC0.

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