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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

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Product Detail

Product Description Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx only, FOR TOPICAL USE ONLY, NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE, Net Contents 118.28 mL (4 fl. oz.), Hill Dermaceuticals, Inc., Sanford, Florida --- NDC 28105-149-04
Recall Number D-218-2013
Classification Class III
Code Info Lot # D110550, Exp. 04/2013.
Product Distributed Qty 8,592 bottles
Reason For Recall Subpotent; 22 month stability timepoint

Event Detail

Event Id 64455
Product Type Drugs
Status Ongoing
Recalling Firm Hill Dermaceuticals, Inc.
City Sanford
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-21
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide