• 23
  • January
    2012

A company that manufactures and sells ointments that are supposed to regrow hair has agreed to recall its products after the Food and Drug Administration accused it of putting active drug ingredients into them without approval. The ointments contain heavy concentrations of Minoxidil, which can cause serious heart and blood pressure problems.

The company, Perfect Image Solutions, LLC, sells a series of products of the same name that it markets as controlling balding and even encouraging the regrowth of hair. It sells separate treatments for men and women in various strengths. The formula combinations for the men's products include five percent Azelaic, an organic compound used to treat hair and skin conditions, and Minoxidil in amounts ranging from five percent up to 15 percent. Perfect Image Solutions also sell's a women's topical ointment with five percent Azelaic and three percent Minoxidil and a shampoo that contains Ketoconazole and salicylic acid.

According to the FDA, the presence of the higher concentrations of Minoxidil, specifically the 10 percent and 15 percent levels, have not been proven to be safe for users. Absorption of Minoxidil can cause heart palpitations and other heart symptoms, as well as low blood pressure. The other drugs in the ointments can cause symptoms ranging from sensitivity to sunburn and skin irritation to burning sensation and rash.

The products were sold nationwide and over the Internet. Consumers should check if they have purchased any of the following products, with the expiration date in parentheses:

• Men's Minoxidil 15% Azelaic 5% Hair regrowth topical, 60mL (October 2013)

• Men's Minoxidil 10% Azelaic 5% Hair regrowth topical, 60mL (October 2013)

• Men's Minoxidil 5% Azelaic 5% Hair regrowth topical, 60mL (September 2014)

• Women's Minoxidil 3% Azelaic 5% Hair regrowth topical, 60mL (November 2013)

• Hair regrowth shampoo enhanced with Ketoconazole and salicylic acid, 180mL (December 2013)

No injuries have been reported so far. The FDA encourages anyone who believes he or she was injured by one of the treatments to contact its MedWatch Adverse Event Reporting program.

Source: Kansas City InfoZine, "Perfect Image Solutions Men & Women's Minoxidil Recall," Jan. 22, 2012