Perfect Image Solutions has issued a recall for hair regrowth products that were deemed “unapproved new drugs” by the Food and Drug Administration because they may pose health hazards.
According to the FDA, the recall applies to all lots of of Men's Minoxidil 15 percent Azelaic 5 percent Hair regrowth topical, 60mL; Men's Minoxidil 10 percent Azelaic 5percent Hair regrowth topical, 60mL; Men's Minoxidil 5 percent Azelaic 5 percent Hair regrowth topical, 60mL; Women's Minoxidil 3 percent Azelaic 5 percent Hair regrowth topical, 60mL; and Hair regrowth shampoo enhanced with Ketoconazole and salicylic acid, 180mL, to the consumer level.
Topical products that contain 10 and 15 percent Minoxidil have not been proven to be safe and may pose a risk to consumers because of the possibility of systemic absorption, according to the FDA. This ingredient may also cause heart palpitations and low blood pressure and associated cardiac symptoms.
Other side effects include:
• The Azelaic acid in the topical products may cause the skin to become more prone to sunburn.
• The Ketoconazole in the shampoo may cause abnormal hair texture and discoloration, rash, itching, skin irritation and dry skin.
• The Salicylic acid in the shampoo may cause temporary burning, itching, stinging or irritation.
There have been no reports of serious injuries linked with the products in this recall.
If you have been injured by an unsafe product, contact Sokolove Law for a free legal consultation and to learn about your options.