D-1660-2012 Class III Terminated

Recalled by Galderma Laboratories, L.P. — Fort Worth, TX

Recall Details

Product Type
Drugs
Report Date
September 5, 2012
Initiation Date
August 15, 2012
Termination Date
February 22, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
17,160 bottles

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,

Reason for Recall

Subpotent; fluocinolone acetonide.

Distribution Pattern

Nationwide and Puerto Rico.

Code Information

Lots J090181-H100089, J090181-J100096, and J090181-K100102.