FDA-Drug2014-11-19Class II
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)
Fougera Pharmaceuticals Inc.
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>.
Sold states
Nationwide and Puerto Rico
Affected count
a) 59,622 Tubes; b) 43,178 Tubes
Manufactured in
60 Baylis Rd, Melville, NY, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0245-2015Don't want to check this manually?
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