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U.S. Department of Health and Human Services

Enforcement Report - Week of September 5, 2012

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Product Detail

Product Description 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,
Recall Number D-1660-2012
Classification Class III
Code Info Lots J090181-H100089, J090181-J100096, and J090181-K100102.
Product Distributed Qty 17,160 bottles
Reason For Recall Subpotent; fluocinolone acetonide.

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.