Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Perfect Image Solutions, LLC Issues Voluntary Recall of
Unapproved Product Due to Potential Health Risk

Contact:

Consumer:
Perfect Image Solutions, LLC
916-791-3230
This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Media:
David Petrillo
916-791-3230

FOR IMMEDIATE RELEASE - January 19, 2012 -Perfect Image Solutions, LLC is voluntarily recalling all lots of Men's Minoxidil 15% Azelaic 5% Hair regrowth topical, 60mL; Men's Minoxidil 10% Azelaic 5% Hair regrowth topical, 60mL; Men's Minoxidil 5% Azelaic 5% Hair regrowth topical, 60mL; Women's Minoxidil 3% Azelaic 5% Hair regrowth topical, 60mL; and Hair regrowth shampoo enhanced with Ketoconazole and salicylic acid, 180mL, to the consumer level. The products are deemed “unapproved new drugs” under the law and U.S. Food and Drug Administration regulations and may present potential health hazards.

Use of these topical products containing 15% and 10% Minoxidil have not been shown to be safe, and could pose a risk to the general public due to the possibility of systemic absorption. Skin abrasions or irritations, such as psoriasis or sunburn, could increase the systemic absorption of topically administered Minoxidil. Minoxidil 15% and 10% could cause low blood pressure, heart palpitations and associated cardiac symptoms. Azelaic acid contained in the topical products could make the skin where it is applied more sensitive to sunburn. Ketoconazole contained in the shampoo product could cause hair discoloration and abnormal hair texture, removal of the curl from permanently waved hair, itching, rash, skin irritation and dry skin. Salicylic acid contained in the shampoo could cause mild, temporary burning, itching, irritation, or stinging.

Perfect Image Solutions, LLC has not received reports of serious injuries associated with the products subject to this voluntary recall.

These products are used to slow or stop hair loss and promote hair regrowth and are packaged in glass-dropper containers or plastic shampoo bottles, and are sold in single units. They are used by men and women generally in middle to late adulthood. The affected product lots include the following lot numbers and expiration dates:
 

Perfect Image Solutions, LLC is notifying its distributors by phone and in writing, and is arranging for return of all recalled products. Consumers that have product which is being recalled should discard it.

Consumers with questions regarding this voluntary recall can contact Perfect Image Solutions, LLC by phone number (916) 791-3230 or e-mail address This e-mail address is being protected from spambots. You need JavaScript enabled to view it , Monday–Friday from 9 AM–5 PM PST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

###

RSS Feed for FDA Recalls Information [what's this?]

Photo: Product Labels

Recalled Product Photos Are Also Available on FDA's Flickr Photostream.

-