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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Event Detail

Event ID 62803
Product Type Drugs
Status Ongoing
Recalling Firm Galderma Laboratories, L.P.
City Fort Worth
State TX
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-15
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide and Puerto Rico.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Capex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, Rx only, For Topical Use Only, 4 fl oz in a 6 oz bottle, Marketed by: Galderma Laboratories, LP, Fort Worth, TX, Mfd. by: Hill Dermaceuticals, Inc., Sanford, FL --- NDC 0299-5500-04, Lots J090181-H100089, J090181-J100096, and J090181-K100102. Class III Subpotent; fluocinolone acetonide. 17,160 bottles D-1660-2012
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