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Capex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, Rx only, For Topical Use Only, 4 ...

FDA Recall #D-1660-2012 — Class III — August 15, 2012

Recall #D-1660-2012 Date: August 15, 2012 Classification: Class III Status: Terminated

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.

Recalling Firm

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

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

17,160 bottles

Distribution

Nationwide and Puerto Rico.

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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