Drug recall D-008-2014

Class III Terminated reported Nov 27, 2013

Product

Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118.28 mL (4 fl. oz.) bottle, 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

K111100 exp.10/13, K111110 exp.10/13, M111240 exp.12/13, and A120012 exp.01/14

Recall details

Recalling firm
Hill Dermaceuticals, Inc., Sanford, FL
Distribution
Nationwide and Puerto Rico.
Type
Voluntary: Firm initiated
Recall initiated
September 8, 2013
Terminated
August 4, 2014