D-0245-2015 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 19, 2014
- Initiation Date
- August 28, 2014
- Termination Date
- June 21, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 59,622 Tubes; b) 43,178 Tubes
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)
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 Pattern
Nationwide and Puerto Rico
Code Information
a) 15 gram lot numbers: 549N, 550N,551N Exp. 1/2015, EB1961, Exp. 2/2017; b) 60 gram lot numbers: 546N, 547N, 548N, Exp. 1/2015, EB0144, Exp. 2/2017