FDA Alert: Dietary Supplements Recalled Because of Undeclared Ingredients
This is a reprint of an FDA Alert.
FDA Alert: Evol Nutrition Associates, Inc./ Red Dawn Issues Voluntary Nationwide Recall of Dietary Supplements Mojo Nights and Mojo Nights for Her Because of Potential Health Risk
FOR IMMEDIATE RELEASE - August 23, 2012 - Kennesaw, GA, Evol Nutrition Associates, Inc./Red Dawn (“Evol Nutrition”) announced today that it is conducting a voluntary nationwide recall of all lots of two dietary supplement products distributed by the company under the names Mojo Nights and Mojo Nights for Her to the consumer level. The products are manufactured by and are products of Mojo Health of Lauderhill, FL. Testing by the U.S. Food and Drug Administration (“FDA”) revealed the presence of undeclared tadalafil and sildenafil in Mojo Nights only, but Evol Nutrition is also recalling Mojo Nights for Her as a precautionary measure. Tadalafil and sildenafil are active ingredients of FDA-approved drugs for Erectile Dysfunction (ED), making Mojo Nights an unapproved new drug.
These undeclared active ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. No illnesses have been reported to the company to date in connection with these products.
These two products were distributed nationwide via retail stores and internet sales between July 2011 and July 2012. All lots of the following packages of Mojo Nights and Mojo Nights for Her are involved in this voluntary recall:
|
Product |
Package Size |
UPC Code |
|
Mojo Nights |
1 capsule |
7 18122 11983 7 |
|
Mojo Nights for Her |
1 capsule |
7 18122 12133 5 |
Evol Nutrition is notifying its customers by certified mail. Customers with stock of the recalled product should destroy it or return for a refund. Consumers who have the recalled product in their possession should stop using the products immediately.
Customers with questions can call 866-639-3865 Monday through Friday between 9 a.m. and 5 p.m. EST for further information. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program 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
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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