Perfect Image Solutions LLC is recalling several hair regrowth products because the active ingredient in the products has not been proven safe, according to the Food and Drug Administration (FDA). Because there are no safety studies on the ingredient, and there is a risk that the solution could be absorbed through the skin, the products are considered illegal and must be removed from the market.
The recall involves 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.
Topical products containing 15 percent and 10 percent Minoxidil have not been shown to be safe. 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. 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.
Consumers who have these products should stop using them and discard them. For more information regarding this voluntary recall contact Perfect Image Solutions, LLC by phone at (916) 791-3230 or e-mail firstname.lastname@example.org, Monday–Friday from 9 AM–5 PM PST.
Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.
Any side effects with this or any other product should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.