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)

Recall Number: D-0245-2015

Firm: Fougera Pharmaceuticals Inc.

Classification: Class II

Status: Terminated

Report Date: 20141119

Initiation Date: 20140828

Termination Date: 20160621

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>.

Product Description

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)

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 &amp; 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

Product Description

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)