FDA Drug recall D-0245-2015
FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET WT 60 grams tubes,…
- FDA Drug
- Class II
- terminated
- Published 2014-11-19
On 2014-11-19 the FDA classified a Class II recall of FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET WT 60 grams tubes,… by Fougera Pharmaceuticals, citing failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0245-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-28 |
| Published | 2014-11-19 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fougera Pharmaceuticals |
| Distribution | US |
Product
FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET WT 60 grams tubes, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0135-15 (15 g) and NDC 0168-0135-60 (60 g)
Reason
Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>.
Identifiers
| code_info | a) 15 gram lot numbers: 549N, 550N,551N Exp. 1/2015, EB1961, Exp. 2/2017; b) 60 gram lot numbers: 546N, 547N, 548N, Exp. 1/2015, EB0144, Exp. 2/2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0245-2015%22
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