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
D-0327-2021
Product summary
- Event
- Event 87608
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 30 mL: 7724 b) 60 mL: 8064 bottles
- Official record key
drug-enforcement:D-0327-2021
Official wording
Reason: CGMP Deviaitons
Code information: a) 30 mL: 1014611 and 1014612, exp 12/2022 b) 60 mL:1014593, 1014594 and 1014595, exp 10/2022
Distribution pattern: Nationwide in the US
Derived failure modes
-
Unknown
CGMP Deviaitons