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
Reported: February 7, 2018 Initiated: November 20, 2017 #D-0336-2018
Product Description
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".
Details
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Units Affected
- 5136 tubes
- Distribution
- Product was distributed throughout the United States.
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: 5136 tubes.
Why was this product recalled? ▼
CGMP Deviations: Market complaints related to "gritty texture".
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 7, 2018. Severity: Moderate. Recall number: D-0336-2018.
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