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>.
Recall initiated: 20140828
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated