Hair Product Voluntarily Recalled Due to Potential Health Risk

January 23, 2012  The Missouri Department of Health and Senior Services received a recall of topical products, which contain 15% and 10% Minoxidil, used to treat male-pattern baldness.

 

Perfect Image Solutions, LLC is voluntarily recalling all lots 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 shampoo, enhanced 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.

 

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 more sensitive to sunburn. Ketaconazole contained in the shampoo product may cause 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 are used to slow or stop hair loss and promote hair regrowth, and are packaged in glass-dropper containers or plastic shampoo bottles, sold in single units. They are used by men and women, generally in their middle to late adulthood. The affected product lots include the following lot numbers and expiration dates:

Minoxidil

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

Perfect Image Solutions, LLC has not received any reports regarding serious incidents associated with their products subject to this voluntary recall.

 

For more information or to view the full recall announcement can be found at: http://www.fda.gov/Safety/Recalls/ucm28855.htm?source=govdelivery

 

Perfect Image Solutions, LLC is notifying its distributors by phone and in writing, and is arranging for return of all recalled products. Consumers that have products that are being recalled should discard them.

 

If you have experienced any adverse side affects from using these Perfect Image Solutions, LLC products, please contact us, as you may be entitled to compensation. Stop by our website and Facebook page, or follow us on Twitter. If you’d like to speak to one of our attorneys, feel free to give us a call at 1-800-246-HURT (4878).

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