March 2021 FDA Recall Drug by Cosette Pharmaceuticals, Inc.
D-0327-2021 - CGMP Deviaitons

This Class II drug recall was voluntarily initiated by Cosette Pharmaceuticals, Inc. on March 25, 2021 for the product Drug. The FDA reported the reason for recall as cgmp deviaitons. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0327-2021

Reason for Recall
CGMP Deviaitons
Initiated
03-25-2021
Reported
04-14-2021
Quantity
a) 30 mL: 7724 b) 60 mL: 8064 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87608
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cosette Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-17-2023
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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