Drug recall D-1180-2014

Class III Terminated reported Apr 2, 2014

Product

SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-506-04

Reason for recall

Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

Lots and codes

13F016A exp. 12/14.

Recall details

Recalling firm
Hill Dermaceuticals, Inc., Sanford, FL
Quantity
7,676 bottles
Distribution
Nationwide and Puerto Rico
Type
Voluntary: Firm initiated
Recall initiated
January 31, 2014
Terminated
February 3, 2015