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FDA Medwatch Alert: Perfect Image Solutions Topical Hair Regrowth Products: Recall - Unapproved Drugs, Risk of Health Hazards

Posted 23 Jan 2012 by Drugs.com

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 Hair regrowth shampoo enhanced with Ketoconazole and salicylic acid, 180mL ISSUE: Perfect Image Solutions recalled all lots of these topical hair regrowth products because they are deemed “unapproved new drugs” under FDA 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 pa ... Read more

Related support groups: Alopecia, Rogaine, Finacea, Azelaic Acid, Azelex, Finevin, Rogaine Extra Strength, Ronoxidil, Rogaine Women's

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