fda approved drug

Keime Inc dba Barry's Vitamins Conducts a Nationwide Voluntary R...

Food and Drug Administration--Recalls  Fri, 11/11/2011 - 15:32

Keime Incorporated announced today that it is conducting a voluntary recall of one lot of the companies dietary supplement product sold under the following name: Virility Max. The company has been informed by representatives of the FDA that lab analysis by FDA for Lot 10090571, found the product contained sulfoaildenafil, an analog of sildenafil.

Sildenafil is an active ingredient of an FDA approved drug for erectile dysfunction (ED), making Virility Max an unapproved drug. 


 

Ethos Environmental, Inc. Issues a Voluntary Recall of Specific ...

Food and Drug Administration--Recalls  Fri, 04/29/2011 - 10:39

Ethos Environmental, Inc. is conducting a voluntary recall because FDA lab analysis has confirmed the presence of Sulfoaildenafil, an analogue of Sildenafil, making these products unapproved new drugs.

Sildenafil is an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredient is not listed on the label for these products.


 

AVNS, Inc. Issues a Voluntary Recall of THE BEST Enhancer

Food and Drug Administration--Recalls  Mon, 04/04/2011 - 10:28

AVNS Inc announced today it is voluntarily recalling THE BEST Enhancement Supplement. AVNS Inc is conducting a voluntary recall after being informed by their manufacturer, Drive Total Energy, that the Food and Drug Administration (FDA) lab analyses found that the products to contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used in the treatment of male Erectile Dysfunction (ED), making these products unapproved new drugs.


 

USA Far Ocean Group Inc. Issues Voluntary Nationwide Recall of X...

Food and Drug Administration--Recalls  Mon, 03/28/2011 - 16:07

USA Far Ocean Group Inc., 1609 W. Valley Blvd., #338, Alhambra, CA 91803, announced today that it is conducting a voluntary nationwide recall of the Company's two supplement products sold under the names X-Hero and Male Enhancer.

The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of X-Hero sample found the product contains sulfosildenafil, the analogue of the active ingredient of an FDA-approved drug used to treat erectile dysfunction (ED), making X-Hero an unapproved drug.


 

Kanec USA, Inc. Issues a Voluntary Recall of Nite Rider Maximum ...

Food and Drug Administration--Recalls  Mon, 01/24/2011 - 13:43

Kanec USA Inc., announced today that it is conducting a voluntary recall of All Lots of the company’s Nite Rider Maximum Sexual Enhancer For Men and STUD Capsule for Men because they were found adulterated with Sildenafil, an FDA approved drug used in the treatment of Erectile Dysfunction (ED), making the products unapproved new drugs.

Representatives of the Food and Drug Administration (FDA) informed Kanec USA, Inc. of the laboratory analysis.


 

Drive Total Energy Issues a Voluntary Recall of Rock Hard Extrem...

Food and Drug Administration--Recalls  Fri, 12/31/2010 - 16:17

Drive Total Energy announced today it is voluntarily recalling the company’s Rock Hard Extreme and Passion Coffee Dietary Supplements.

Drive Total Energy is conducting the voluntary recall after being informed by the Food and Drug Administration (FDA) that lab analyses found that the products to contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used in the treatment of male Erectile Dysfunction (ED), making these products unapproved new drugs.

The active drug ingredient is not listed on the product label.


 

Intelli Health Products, Issues an Expansion to All Lots of thei...

Food and Drug Administration--Recalls  Mon, 12/06/2010 - 11:48

Intelli Health Products announced today that it is expanding their voluntary nationwide recall of Duro Extend Capsules For Men, to include all lot codes.

Intelli Health Products is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that laboratory analysis of Duro Extend Capsules For Men found the product to be adulterated with Sulfoaidenafil, an analogue of Sildenafil which is an FDA approved drug used in the treatment of Erectile Dysfunction (ED), making it an unapproved new drug.


 

Duro Extend Capsules for Men: Recall - Undeclared Drug Ingredien...

NCCAM Featured Content  Tue, 11/09/2010 - 15:31

ISSUE: Lab analysis has found Duro Extend Capsules for Men to contain Sulfoaidenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction, making the product an unapproved drug.

The analogue 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.


 

Glow Industries, Inc. Issues Nationwide Recall of Mr. Magic Male...

Food and Drug Administration--Recalls  Wed, 08/18/2010 - 14:41

Glow Industries, Inc., Perrysburg, OH, announced today that it is initiating a voluntary nationwide recall of the company's product sold under the name of Mr.

Magic Male Enhancer from Don Wands. Glow Industries, Inc. is conducting this voluntary recall after being informed by the Food and Drug Administration (FDA) that lab analysis has found the Mr.

Magic Male Enhancer from Don Wands capsules to contain Hydroxythiohomosildenafil and Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used in the treatment of male Erectile Dysfunction (ED), making Mr.


 

Prolatis’ Issues a Voluntary Nationwide Recall of its product ...

Food and Drug Administration--Recalls  Thu, 08/12/2010 - 16:44

Salt Lake City, UT announced today that it is conducting a voluntary nationwide recall of the company’s product sold under the name Prolatis’.

Prolatis’ is conducting a voluntary recall after being informed by the Food and Drug Administration (FDA) that lab analysis has found Prolatis’ to contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED), making Prolatis’ an unapproved drug.

The active drug ingredient is not listed on the product label. Product manufactured prior to August 9, 2010 is included in this recall.