FDAClass IIApril 14, 2021

Mometasone Furoate Topical Solution recall: CGMP Deviations

Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-0701-85) and b) 60 mL (NDC 0713-0701-53), Rx Only, Distributed by: Cosette Pharmaceuticals, Inc., South Plainfield, NJ 07080

Why was Mometasone Furoate Topical Solution recalled?

CGMP Deviaitons

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?

a) 30 mL: 1014611 and 1014612, exp 12/2022 b) 60 mL:1014593, 1014594 and 1014595, exp 10/2022

Product
Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-0701-85) and b) 60 mL (NDC 0713-0701-53), Rx Only, Distributed by: Cosette Pharmaceuticals, Inc., South Plainfield, NJ 07080
Recalling firm
Cosette Pharmaceuticals, Inc.
Quantity
a) 30 mL: 7724 b) 60 mL: 8064 bottles
Distribution
Nationwide in the US
Recall date
April 14, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls