Drug recall D-1646-2012

Class III Terminated reported Aug 22, 2012

Product

Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl oz (118.28mL) bottle, Rx only, FOR TOPICAL USE ONLY NOT, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-149-04

Reason for recall

Subpotent; fluocinolone acetonide

Lots and codes

Lot Numbers: -Scalp Oil: H100084 (exp 08/12), H100086 (08/12), J100093 (exp 08/12), J100094 (exp 09/12), J100097 (exp 09/12), K100101 (exp 09/12), K100103 (exp 10/12), K100104 (exp 10/12), K100108 (exp 10/12), K100112 (exp 10/12), L100860 (exp 11/12), L100890 (exp 11/12), L100910 (exp 11/12).

Recall details

Recalling firm
Hill Dermaceuticals, Inc., Sanford, FL
Quantity
161,064 bottles
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
May 8, 2012
Terminated
February 10, 2015