August 2014 FDA Recall Drug by Fougera Pharmaceuticals Inc.
D-0245-2015 - Failed Stability Specifications

This Class II drug recall was voluntarily initiated by Fougera Pharmaceuticals Inc. on August 28, 2014 for the product Drug. The FDA reported the reason for recall as failed stability specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0245-2015

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>.
Initiated
08-28-2014
Reported
11-19-2014
Quantity
a) 59,622 Tubes; b) 43,178 Tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68839
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fougera Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-21-2016
Product Description About Product Description
Full technical description of the 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)

Batch or Lot Expiration Information

Lot# 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