Drug recall D-1174-2014

Class III Terminated reported Apr 2, 2014

Product

Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl. oz., Rx only. Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-149-04

Reason for recall

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

Lots and codes

12J030C exp. 03/14, 12L041C exp. 05/14

Recall details

Recalling firm
Hill Dermaceuticals, Inc., Sanford, FL
Quantity
14,226 bottles
Distribution
Nationwide and Puerto Rico
Type
Voluntary: Firm initiated
Recall initiated
January 31, 2014
Terminated
February 3, 2015