FDA recall D-0245-2015

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 for recall

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>.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2014-08-28

Report date

2014-11-19

Termination date

2016-06-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Melville, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0245-2015