D-0327-2021 Class II Terminated

Recalled by Cosette Pharmaceuticals, Inc. — South Plainfield, NJ

Recall Details

Product Type
Drugs
Report Date
April 14, 2021
Initiation Date
March 25, 2021
Termination Date
July 17, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
a) 30 mL: 7724 b) 60 mL: 8064 bottles

Product Description

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

Reason for Recall

CGMP Deviaitons

Distribution Pattern

Nationwide in the US

Code Information

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