Cosette Pharmaceuticals, Inc.: Drug Recall

Recall #D-0327-2021 · 03/25/2021

Class II: Risk

Recall Details

Recall Number
D-0327-2021
Classification
Class II
Product Type
Drug
Recalling Firm
Cosette Pharmaceuticals, Inc.
Status
Terminated
Date Initiated
03/25/2021
Location
South Plainfield, NJ, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
a) 30 mL: 7724 b) 60 mL: 8064 bottles

Reason for Recall

CGMP Deviaitons

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

Distribution Pattern

Nationwide in the US

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.