Perfect Image Solutions, LLC recently announced a recall of 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; and Hair regrowth shampooenhanced with Ketoconazole and salicylic acid, 180mL, to the consumer level. The products are deemed “unapproved new drugs” under the law and U.S. Food and Drug Administration regulations and may present potential health hazards. The company has not received reports of serious injuries associated with the products.
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 palpitations and associated cardiac symptoms. Azelaic acid contained in the topical products could make the skin where it is applied 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.
|Product Name||Lots||Expiration||UPC Number|
|Men’s Minoxidil 15% Azelaic 5% Hair regrowth topical, 60mL.||All||Up until Oct. 2013||736211275813|
|Men’s Minoxidil 10% Azelaic 5% Hair regrowth topical, 60mL.||All||Up until Oct. 2013||736211276018|
|Men’s Minoxidil 5% Azelaic 5% Hair regrowth topical, 60mL.||All||Up until Sept. 2014||736211276117|
|Women’s Minoxidil 3% Azelaic 5% Hair regrowth topical, 60mL.||All||Up until Nov. 2013||736211274519|
|Hair regrowth shampoo enhanced with Ketoconazole and salicylic acid, 180mL.||All||Up until Dec. 2013||736211276414|
The product can be identified by the name Perfect Image Solutions on the container. Product was distributed nationwide or worldwide via the internet.
According to the recall notice, consumers should discard the product and contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Consumers with questions regarding this voluntary recall can contact Perfect Image Solutions, LLC by phone number (916) 791-3230 or e-mail address firstname.lastname@example.org, Monday–Friday from 9 AM–5 PM PST.
If you have suffered an injury due to an unapproved drug, a defective products attorneymay be able to help you pursue the compensation you deserve. For more information, call 1-888-BURNETTI.