FDA Drug recall D-0327-2021
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…
- FDA Drug
- Class II
- terminated
- Published 2021-04-14
On 2021-04-14 the FDA classified a Class II recall of 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, citing CGMP Deviaitons.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0327-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-25 |
| Published | 2021-04-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cosette Pharmaceuticals |
| Distribution | US |
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
CGMP Deviaitons
Identifiers
| code_info | a) 30 mL: 1014611 and 1014612, exp 12/2022 b) 60 mL:1014593, 1014594 and 1014595, exp 10/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0327-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.