Drug recall D-1647-2012

Class III Terminated reported Aug 22, 2012

Product

Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01%, Body Oil, 4 fl. oz. (118.28mL ), Rx only, FOR TOPICAL USE ONLY, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-150-04

Reason for recall

Subpotent; fluocinolone acetonide

Lots and codes

Lot Numbers: -Body Oil: J100095 (exp 09/12), J100099 (exp 09/12), K100106 (exp 10/12), K100111 (exp 10/12), L100872 (exp 11/12), L100880 (exp 11/12), D110560 (exp 04/13).

Recall details

Recalling firm
Hill Dermaceuticals, Inc., Sanford, FL
Quantity
111,816 bottles
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
May 8, 2012
Terminated
February 10, 2015