FDA recall D-0327-2021
Cosette Pharmaceuticals, Inc. · Class II · drug
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
Reason for recall
CGMP Deviaitons
Distribution
Nationwide in the US
Key facts
- Status
- Terminated
- Initiation date
- 2021-03-25
- Report date
- 2021-04-14
- Termination date
- 2023-07-17
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- South Plainfield, NJ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0327-2021