Drug recall D-1175-2014

Class III Terminated reported Apr 2, 2014

Product

Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-150-04

Reason for recall

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

Lots and codes

13D010A exp. 10/14.

Recall details

Recalling firm
Hill Dermaceuticals, Inc., Sanford, FL
Quantity
8,734 bottles
Distribution
Nationwide and Puerto Rico
Type
Voluntary: Firm initiated
Recall initiated
January 31, 2014
Terminated
February 3, 2015