Class II
Terminated
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)
This recall has been terminated (originally issued November 19, 2014).
- Company
- Fougera Pharmaceuticals Inc.
- Recall Initiated
- August 28, 2014
- Posted
- November 19, 2014
- Recall Number
- D-0245-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 59,622 Tubes; b) 43,178 Tubes
- Firm Location
- Melville, NY, United States
- Official Source
- View on FDA website ↗
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
Lot / Code Info
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
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