Topical Hair Regrowth Products
January 23, 2012
FDA and Perfect Image Solutions, LLC notified the public that the following hair regrowth topical products are considered “unapproved new drugs” by FDA and all lots of these products have been recalled:
- Men's Minoxidil 15% Azelaic 5% (60 mL); UPC 736211275813
- Men's Minoxidil 10% Azelaic 5% (60 mL); UPC 736211276018
- Men's Minoxidil 5% Azelaic 5% (60 mL); UPC 736211276117
- Women's Minoxidil 3% Azelaic 5% (60 mL); UPC 736211274519
- Shampoo including Ketoconazole and salicylic acid (180 mL); UPC 736211276414
The safety of minoxidil topical products in concentrations of 10% and 15% has not been demonstrated. Minoxidil in these products may be absorbed systemically, resulting in risk of adverse events such as low blood pressure and cardiac symptoms. Sunburn, skin irritation, or certain skin conditions may increase absorption of topical minoxidil. Topical use of azelaic acid increases the risk of sunburn at the application site. The recalled shampoo contains ketoconazole, which may discolor or change the texture of hair, or cause itching, irritation, rash or skin dryness. The shampoo also contains salicylic acid which may cause skin irritation, itching, or transient burning. No serious adverse events related to these recalled products have been reported to the manufacture to date.
These hair regrowth products were distributed via the internet. Do not use any of the recalled products, but discard them immediately in a safe manner. Contact the manufacturer by calling 916-791-3230 or by email at email@example.com with any further questions about the recall.
See the following links for more information:
- MedWatch Alert
- Firm Press Release
January 23, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.