January 23, 2012
Perfect Image Solutions Topical Hair Regrowth Products: Recall

Perfect Image Solutions has recalled all lots of the topical hair regrowth products listed below, as result of them being deemed “unapproved new drugs” under FDA regulations and possibly presenting potential health hazards.

• 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
  

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, owing to the possibility of systemic absorption, which could be increased by kin abrasions or irritations, such as psoriasis or sunburn. Minoxidil 15% and 10% could cause low blood pressure, heart palpitations and associated cardiac symptoms. Azelaic acid contained in the topical products could cause skin to which it is applied to become 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. These products, used to slow or stop hair loss and promote hair regrowth, 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 product can be identified by the name Perfect Image Solutions on the container. The recalled product was distributed nationwide or worldwide via the internet and should be discarded by consumers.

Read the MedWatch safety alert at www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm288562.htm