Fougera Pharmaceuticals Inc. recalls FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET
Recalled November 19, 2014 · FDA recall D-0245-2015 · Fougera Pharmaceuticals
Hazard
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>. · FDA Class II
Units
a) 59,622 Tubes; b) 43,178 Tubes
Sold at
Nationwide and Puerto Rico
Description
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>.
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)
Manufacturer(s)
Fougera Pharmaceuticals Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →