Natural Wellness, Inc. Issues a Nationwide Voluntary Recall of Masxtreme Capsules, Marketed as a Dietary Supplement

Natural Wellness is announcing that it is conducting a nationwide voluntary recall of MasXtreme, Lot # 907043, UPC 094922300805. Laboratory analysis conducted by FDA has determined the product contains undeclared amounts of Aminotadalafil, an analog of tadalafil. Tadalafil is an FDA-Approved drug used to treat erectile dysfunction (ED), making the MasXtreme an unapproved new drug.

Risk Statement: FDA advises that this poses a threat to consumers because aminotadalafil 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.

MasXtreme is sold in blister packs containing one (1) capsule. The product is distributed nationwide by Natural Wellness Inc. This product is being promoted for increasing desire and sexual performance. The product is sold without medical prescription. No adverse events have been reported.

Consumers who have purchased MasXtreme tablets are urged to immediately discontinue their use and return the product to their place of purchase or directly to Natural Wellness Inc. at 440 S Federal Hwy, Suite 107, Deerfield Beach, FL 33441. Consumers with questions regarding this recall may contact the company at 954-570-6662 Monday through Friday 8 am to 4 pm. Consumers who have purchased this product and have medical concerns should consult with their health care providers.

Adverse reaction 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.htm9. Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at www.fda.gov/MedWatch/getforms.htm10. Mail to address on the pre-addressed form. Fax: 1-800-FDA-0178.

This recall is being conducted in cooperation with the U.S. Food and Drug Administration (FDA).

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EZVille, Ltd. Issues a Voluntary Nationwide Recall of Revivexxx® Extra Strength Found to Contain an Undeclared Drug Ingredient

EZVille, Ltd. of Ronkonkoma, NY, has been informed by the US Food and Drug Administration (FDA) that FDA lab analysis of Revivexxx® Extra Strength distributed by the company was found to contain undeclared tadalafil. Tadalafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making Revivexxx® Extra Strength an unapproved drug.

FDA advises that this poses a threat to consumers because tadalafil 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.

Revivexxx® Extra Strength is marketed as a dietary supplement sexual enhancer for men. Revivexxx® Extra Strength is packaged in a single dose blister pack containing one oral tablet and bears UPC 8 35470 00207 9. All lots of this product with expiration dates including and prior to August 2013 currently available on the market are being recalled. The product was sold to distributors and retail stores nationwide and via internet sales.

No illnesses or injuries have been reported to the company to date in connection with this product.

EZVille, Ltd. is taking this voluntary action because of the concern for the health and safety of consumers. The company has discontinued distribution of these affected products. It sincerely regrets any inconvenience to our customers.

Consumers should not consume Revivexxx® Extra Strength and should return it immediately to the place of purchase for a full refund. Consumers should contact their physician if they have experienced any problems that may be related to taking this product. Consumers with questions should contact Eric Budzinski at 1-866 -673-8483, Monday through Friday, 9:00 am to 5:30 pm, EDT.

Consumers and health care professionals should report adverse events that may be related to the use of this product to the FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm9, by phone at 1-800-FDA-1088 or by returning the postage-paid FDA form 3500 which may be downloaded from www.fda.gov/MedWatch/getforms.htm10 by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 or fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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Nature & Health Co. Issues Voluntary Nationwide Recall of Libimax, a Product Marketed as a Dietary Supplement

Nature & Health Co., located in Brea, California, announced today that it is conducting a voluntary nationwide recall of the company's supplement product sold under the name Libimax. The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Libimax samples found the product contains tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED), making Libimax an unapproved drug. FDA advised that this poses a threat to consumers because tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. According to the FDA, consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. FDA advises that ED is a common problem in men with these conditions, and they may seek products to enhance sexual performance. FDA advises that tadalafil, may cause side effects, such as headaches and flushing.

The recalled Libimax is sold as a 1 capsule individual pack or 10-capsule and 20-capsule plastic bottles in retail stores in California, Georgia, Illinois, Texas, and Ohio. The product label neither states it contains tadalafil nor warns consumers with high blood pressure not to ingest the product.

Consumers who have Libimax in their possession should stop using it immediately and contact their physician if they experienced any problem that may be related to taking this product. The public is encouraged to submit a report of any serious adverse events that occur with the use of Libimax to the FDA's MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm ], by phone [1-800-FDA-1088], or by returning the postage-paid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].

Nature & Health Co. is committed to providing accurate information about its products because of concern for the health and safety of consumers. Nature & Health Co. is working with the FDA in the recall process. It sincerely regrets any inconvenience to customers.

No illnesses have been reported to the Company to date in connection with this product.

Consumers should return any unused Libimax, for a refund of the full purchase price or price for the unused portion, to the retail location where it was purchased or to contact Nature & Health directly at (714) 257-1800 Monday – Friday, 8am to 5pm or by email at sales@naturenhealth.com to receive further instructions for returning the product or with any questions.

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