FDAClass IIFebruary 7, 2018

Glenmark Mometasone Furoate Cream recall: CGMP Deviations

Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: Glenmark Pharmaceuticals Ltd. Village Manufactured for: Glenmark…

Why was Glenmark Mometasone Furoate Cream recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Batch Number: 05170598; Exp. 03/19

Product
Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: Glenmark Pharmaceuticals Ltd. Village Manufactured for: Glenmark…
Recalling firm
Glenmark Pharmaceuticals Inc., USA
Quantity
5136 tubes
Distribution
Product was distributed throughout the United States.
Recall date
February 7, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls