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U.S. Department of Health and Human Services

Enforcement Report - Week of August 22, 2012

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Product Detail

Product Description 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
Recall Number D-1647-2012
Classification Class III
Code Info 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).
Product Distributed Qty 111,816 bottles
Reason For Recall Subpotent; fluocinolone acetonide

Event Detail

Event Id 62607
Product Type Drugs
Status Ongoing
Recalling Firm Hill Dermaceuticals, Inc.
City Sanford
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-08
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide