Recall: Minoxidil Azelaic hair growth products—Not an approved drug

Jan 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.

The recalled products were distributed nationwide or worldwide via the Internet and include:

•Men's Minoxidil 15 percent Azelaic 5 percent Hair regrowth topical (60mL), expiration up until Oct. 2013, UPC 736211275813.

•Men's Minoxidil 10 percent Azelaic 5 percent Hair regrowth topical (60mL), expiration up until Oct. 2013, UPC 736211276018.

•Men's Minoxidil 5 percent Azelaic 5 percent Hair regrowth topical (60mL), expiration up until Sept. 2014UPC 736211276117.

•Women's Minoxidil 3 percent Azelaic 5 percent Hair regrowth topical (60mL), expiration up until Nov. 2013, UPC 736211274519.

•Hair regrowth shampoo enhanced with Ketoconazole and salicylic acid (180mL), expiration up until Dec. 2013, UPC 736211276414.

The affected recalled products are packaged in glass-dropper containers or plastic shampoo bottles, and are sold in single units.

The recalled topical products containing 15 percent and 10 percent 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 percent and 10 percent could cause low blood pressure, heart palpitations and associated cardiac symptoms. And 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. In addition, Salicylic acid contained in the shampoo could cause mild, temporary burning, itching, irritation, or stinging.

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

Perfect Image Solutions is notifying its distributors and arranging for return of all recalled products. Consumers that have a product being recalled should discard it. For more information call Perfect Image Solutions at 916-791-3230, or e-mail dave@perfectimagesolutions.com.

You should contact your physician or healthcare provider if you 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 can also be reported to the FDA's MedWatch Adverse Event Reporting program.

Source

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