Some topical hair regrowth products are being recalled for health hazards, the U.S. Food and Drug Administration just announced.
All lots of the topical hair regrowth product by Perfect Image Solutions have been recalled because they are deemed “unapproved new drugs” under FDA regulations, and may present potential health hazards, the agency said. The recalled topical hair regrowth products include the following:
- 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 percent 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 systemic absorption of topically administered Minoxidil.
Minoxidil 15 and 10 percent could lead to low blood pressure, heart palpitations, and associated cardiac symptoms. Azelaic acid contained in the recalled products could leave skin where the product was applied, more sensitive to sunburn. Also, ketoconazole contained in the shampoo product could cause hair discoloration and abnormal hair texture; removal of the curl from permanently waved hair; and itching, rash, skin irritation, and dry skin. Salicylic acid contained in the shampoo could cause mild, temporary burning, itching, irritation, or stinging.
These unapproved, recalled products are used to slow or stop hair loss and promote hair regrowth. The products are packaged in glass-dropper containers or in plastic shampoo bottles and are sold in single units. The recalled product is used by men and women who are generally in middle to late adulthood. The words “Perfect Image Solutions” can be found on the container.
The recalled Perfect Image Solutions products were distributed nationwide or worldwide via the Internet. Consumers are advised to discard the recalled products and Perfect Image Solutions, LLC said it is notifying its distributors by telephone and in writing, and is arranging for return of all recalled products. Perfect Image Solutions, LLC can be reached by telephone at 1.916.791.3230 or by email address at email@example.com, Monday–Friday from 9:00 a.m. to 5:00 p.m., Pacific Standard Time (PST).
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax: Online:www.fda.gov/medwatch/report.htm; Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form; Fax: 1-800-FDA-0178.