Prolatis’ Issues a Voluntary Nationwide Recall of its product Prolatis’ Marketed as Dietary Supplement prior to August 9, 2010

Prolatis’ – 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. Prolatis’ is sold nationwide in double blister packs and 40 count bottles.

This recall is being conducted as a precautionary measure. No illnesses or adverse effects have been reported to the company to date in connection with this product.

The undeclared ingredient may pose a threat to consumers because 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. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Prolatis’ advises any customer in possession of Prolatis’ to return the product for a full credit towards the new product. Customers can call 1.877.286.5056 for instructions on the return and credit process.

Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm9], 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 [1-800-FDA-0178].

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Novacare LLC Conducts Voluntary Nationwide Recall of Products Found to Contain Undeclared Drug Ingredient

Novacare LLC announced today that it is conducting a voluntary nationwide recall of products sold under the following names: Stiff Nights, Aziffa, Size Matters, Erex, Mojo, Hard Drive, Eyeful, Red Magic, Straight Up, Zotrex, Monster Excyte, WOW, Xaitrex, Verect, Prolatis, Xytamax, Maxyte, Libidinal, OMG, OMG45, and Zilex (with Golden Spear).

Novacare LLC has been informed by representatives of the Food & Drug Administration (FDA) that the products appear to contain sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction. "Sulfoaildenafil" is not declared on the product labels. The undeclared ingredient 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.

The recalled products listed above were distributed in bottles and/or "blister cards" to retailers and via internet sales. All lots of the above-named products with manufacture or distribution dates prior to June 17, 2010 are being recalled.

This recall is being conducted as a precautionary measure. No illnesses or adverse effects have been reported to the company to date in connection with these products.

Customers who have any of the above-named products in their possession should stop using them immediately and contact their physician if they have experienced any problems that may be related to taking these products.

Consumers and healthcare professionals should report any adverse events that may be related to the use of the above-named products to the FDA's Med Watch Adverse Event Reporting Program online at www.fda.gov/medwatch/report.htm9, 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.htm10 by mail to FDA Med Watch, HF-2, 5600 Fishers Lane, Rockville, MD 20852-9787 or fax to 1-800-FDA-0178.

Novacare LLC is conducting this recall with the knowledge of the FDA. Consumers should return any unused product to the place of purchase or contact Novacare LLC directly at 801-290-1738, Monday – Friday, 10 am to 4 pm MDT.

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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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INZ Distributors Inc./Magic Power Coffee Inc. Conducts a Voluntary Nationwide Recall of Magic Power Coffee Dietary Supplement

INZ DISTRIBUTORS INC./MAGIC POWER COFFEE INC. of Brooklyn, NY announced June 25 that it is conducting a voluntary nationwide recall of the dietary supplement product sold under the name, Magic Power Coffee.

The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis of one lot of the product by the FDA found that the product contains undeclared hydroxythiohomosildenafil, similar in structure to Sildenafil, an FDA-approved drug used for the treatment of male Erectile Dysfunction (ED), making Magic Power Coffee an unapproved drug. The hydroxythiohomosildenafil drug ingredient is not listed on the product label.

Hydroxythiohomosildenafil 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.

Magic Power Coffee is distributed nationwide on Internet sites and online auctions by multiple independent distributors participating in an online multi-level marketing program. It is sold in a 2-serving box with UPC 718122686872 and a 12-serving carton containing six 2-serving boxes with UPC 718122686773. All production dates up until 05/08/2010 are being recalled.

To date, no illnesses have been reported to the company or the FDA in connection with this product.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.

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.htm1, 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.htm2 by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 or fax to 1-800-FDA-0178.

Consumers should return any unused product to the place of purchase for full refund or contact INZ Distributors Inc./Magic Power Coffee Inc. at (718) 313-1579, Monday – Friday, 10 am to 6 pm EDT, for further instructions.

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Kanec USA Inc., Issues a Voluntary Nationwide Recall of Stud Capsule For Men Marketed as Dietary Supplements

KANEC USA INC, 5061, South State Road 7. Ste 602, Davie FL 33314, announced today that it is conducting a voluntary nationwide recall of Stud Capsule For Men Lot #060607-01/060108-01 Exp 6-2013. Kanec USA Inc, is conducting this recall after being informed by representatives of the the Food and Drug Administration (FDA) that laboratory analysis of Stud Capsule Lot 060607-01/060108-01 Exp 6-2013 sample found the product to be adulterated with Sildenafil, an FDA approved drug used in the treatment of Erectile Dysfunction(ED). Making it an unapproved new drug.

Use of this product may pose a threat to consumers because 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. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Stud Capsule For Men are sold nationwide. The products are sold as a blister pack containing one capsule per unit of use 24-packs in a Box. Lot number and expiration date appears on the seal.

Consumers who have Stud Capsule For Men Lot 060607-01/060108-01 Exp 6-2010 in their possession should stop using them immediately.

In the event of any adverse side effects due to the consumption of these products, consumers should contact a physician immediately. Any adverse events that may be related to the use of these products should be reported to the FDA's Med Watch Program by fax at 1-800-FDA-0178 or by mail at Med Watch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787. or on the Med watch website at http:www.fda.gov/safety/medwatch/default.htm1

The Company is advising consumers to return any unused Stud Capsule For Men, to the retail location from which it was purchased or to the Company directly if it was purchased from the Company as a part of its Direct Response Program. Consumers can send unused capsule to directly to the company.

KANEC USA INC
5061 SOUTH STATE ROAD 7, U602
DAVIE FL 33314
Phone: 954-583-5840
Fax: 954-583-5885



KANEC USA INC., conducts stringent quality control testing on both raw materials and finished products. Previous testing protocols did not include a test for the presence of Sildenafil but KANEC USA INC., assures consumers that this deficiency is being rectified. KANEC USA INC., apologizes for any inconvenience and expresses its concern for the health of consumers by conducting a voluntary recall action. KANEC USA INC., promises to ensure quality and integrity of all its products and the company is working closely with the FDA in the recall process.

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Atlas Operations, Inc. Issues a Nationwide Voluntary Recall of Specific Lots of Sexual Enhancement Products Marketed as Dietary Supplements

Atlas Operations, Inc. announced today that it is conducting a voluntary nationwide recall of the company's dietary supplements for sexual enhancement sold under Lot Numbers 494, 520C, 520B, 520A, 520, 521, 705, 706, 779 & 807.

These products are currently being sold as a dietary supplement throughout the U.S. Atlas Operations, Inc. is conducting a voluntary recall after being informed by the Food and Drug Administration (FDA) that a lab analyses found that the products tested from certain batches of the following products Rock Hard T12-705-09, R52-705-09, 72 hrs B54-708-09, Stamin It R2-705-08, Finally On Demand R26-706-09, R27-706-09, Sexual Surge H49-705-09, Staminil T25,705-09, Virect T29-705-09 contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED) making these products an unapproved drug. The active drug ingredient is not listed on the product label.

The undeclared ingredient may pose a threat to the consumer because the interaction of the analogue with some prescription drugs (such as nitroglycerin) may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take other prescription drugs. Erectile Dysfunction is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.



Dietary Supplements Sold Under Lot Numbers


Lot Number ###-494-##
Brand Name

Packaging

Expiration Date
Aspire One

Capsules, all counts

All Dates
Lot Number ###-520C-##
Brand Name

Packaging

Expiration Date
Sex Enhancer

Capsules, all counts

All Dates
Lot Number ###-520B-##
Brand Name

Packaging

Expiration Date
Staminil

Capsules, all counts

All Dates
Sexual Surge

Capsules, all counts

All Dates
Love Fuel

Capsules, all counts

All Dates
Lot Number ###-520A-##
Brand Name

Packaging

Expiration Date
Staminil

Capsules, all counts

All Dates
Sexual Surge

Capsules, all counts

All Dates
Love Fuel

Capsules, all counts

All Dates
Lot Number ###-520-##
Brand Name

Packaging

Expiration Date
Vaxitrol

Capsules, all counts

All Dates
Lot Number ###-521-##
Brand Name

Packaging

Expiration Date
Love Fuel 2

Capsules, all counts

All Dates
Lot Number ###-705-##
Brand Name

Packaging

Expiration Date
Erexa

Capsules, all counts

All Dates
Zenerect

Capsules, all counts

All Dates
Arousin

Capsules, all counts

All Dates
72 Hours

Capsules, all counts

All Dates
Bulk- Unlabeled

Capsules, all counts

All Dates
Enhancement

Capsules, all counts

All Dates
Red Hot Sex

Capsules, all counts

All Dates
Sexual Surge

Capsules, all counts

All Dates
Libiplus

Capsules, all counts

All Dates
Erexxx

Capsules, all counts

All Dates
Tacktol

Capsules, all counts

All Dates
Amour for him

Capsules, all counts

All Dates
Erousa

Capsules, all counts

All Dates
Rockhard

Capsules, all counts

All Dates
Staminil

Capsules, all counts

All Dates
Ezerex

Capsules, all counts

All Dates
Topviril

Capsules, all counts

All Dates
Vierect

Capsules, all counts

All Dates
APL

Capsules, all counts

All Dates
Clyamax

Capsules, all counts

All Dates
Lot Number ###-706-##
Brand Name

Packaging

Expiration Date
Love Fuel

Capsules, all counts

All Dates
Rainbow Rocket

Capsules, all counts

All Dates
Finally On Demand

Capsules, all counts

All Dates
Xtremexcite

Capsules, all counts

All Dates
Whatzup

Capsules, all counts

All Dates
Lot Number ###-807-##
Brand Name

Packaging

Expiration Date
Depth Charge

Capsules, all counts

All Dates



**Lot numbers may or may not contain dashes. The first three and last two digits and letters are insignificant.
***If you have a product with a different name but the same lot number please contact Atlas Operations, Inc. for recall instructions.

Our laboratories have identified that one of the raw ingredients was tainted with Sulfoaildenafil. Atlas Operations takes this recall very seriously and recommits to the diligent work required in ensuring its products remain free of any potentially unapproved chemicals. We take the utmost pride in our products' quality control without compromising our customer's health.

We urge consumers who have purchased these products to discontinue their use and return to their place of purchase. You may also return products directly to Atlas Operations. Customers can call Atlas Operations at 1-800-466-4444 Monday through Friday from 9:00 am - 5:00 pm EST for instructions on the return and refund process.

It is the position of Atlas Operations, Inc. that we did not in any way knowingly or intentionally violate the law with regard to the distribution of these products.

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.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.

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RockHard Laboratories Issues a Voluntary Nationwide Recall of Specific Lots of RockHard Weekend Marketed as Dietary Supplement

RockHard Laboratories announced today that it is conducting a voluntary nationwide recall of the company’s dietary supplement sold under the name RockHard Weekend (RHW) specific to the following Lot Numbers:

Blister Pack: T12 705 08 (exp: 10/11) / T12 705 09 (exp: 3/12, 8/12)
3ct Bottle: R417 0509 (exp: 09/12)
8ct Bottle: T237-0509 (exp: 06/12)

RockHard Laboratories is conducting a voluntary recall after being informed by the Food and Drug Administration (FDA) that voluntary lab analysis found that RHW, specific to the above lot numbers, contains sulfoaildenfil, an analogue of Sildenfil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED) making RockHard Weekend an unapproved drug. The active drug ingredient is not listed on the product label.

The undeclared ingredient may pose a threat to consumers because 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. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

RockHard Laboratories takes the upmost pride in its quality control by outsourcing production to a certified, independent lab. It is through this outside lab that RockHard Laboratories maintains the highest quality standards possible and can quickly take action. RockHard Laboratories has identified that one of the lab’s raw ingredients, sourced from China, was being unknowingly tainted with sulfoaildenfil. RockHard Laboratories takes this recall very seriously and recommits to the diligent work required in ensuring its products remain free of any potentially unapproved chemicals.

RHW is sold nationwide in single blisters, 3-count and 8-count bottles. RockHard Laboratories advises any customers in possession of RHW to return any unused product for a full refund to the company directly. Customers can call 1.800.562.0543 for instructions on the return and refund process.

RockHard Laboratories is committed to improving its product and avoiding future recall issues by sourcing higher quality raw ingredients and expanding testing. RockHard Laboratories promises its customer the highest possible quality and welcomes the recall process as further evidence of our commitment to our brand, products and consumers.

Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm], 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].

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Nutracoastal Trading LLC Expands Its voluntary nationwide recall of Steam Dietary supplement

Nutracoastal Trading LLC announced today that it is expanding its July 28th, 2009 voluntary nationwide recall of the company's dietary supplement product sold under the following name: STEAM.

The Company has found by lab analysis that Lot 90260 contains Tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED), making STEAM DIETARY SUPPLEMENT an unapproved drug. The active drug ingredient is not listed on the product label. The undeclared ingredient 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. Additionally, the product may cause side effects, such as headaches and flushing.

The recalled product listed below was distributed in white plastic bottles to retail stores nationwide.

Brand Name Size Lot EXP. UPC

STEAM 1 Bottle – 5 Capsules 90260 6 11 8 52263 30033 1

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

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.

Any adverse events that may be related to the use of this product should be reported 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].

The FDA has been apprised of this action.

Nutracoastal Trading LLC, a Delaware Limited Liability Company, is committed to providing accurate information about its products because of concerns for the health and safety of consumers. It sincerely regrets any inconvenience to customers.

Consumers should return any unused product to the retail location where they were purchased or contact Nutracoastal Trading LLC directly at 866-803-2434 Monday – Friday, 9 am to 5 pm EDT.

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Nutracoastal Trading LLC conducts voluntary nationwide recall of STEAM Dietary supplement lot 80214

Nutracoastal Trading LLC announced today that it is conducting a voluntary nationwide recall of the company's dietary supplement product sold under the following name: STEAM.

The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA for Lot 80214 found that the product contains sulfoaildenafil, an analog of sildenafil. Sildenafil is an active ingredient of an FDA-approved drug for erectile dysfunction (ED), making STEAM DIETARY SUPPLEMENT an unapproved drug. The active drug ingredient is not listed on the product label. The undeclared ingredient 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. Additionally, the product may cause side effects, such as headaches and flushing.

The recalled product listed below was distributed in white plastic bottles to retail stores nationwide.

STEAM 1 Bottle - 5 Capsules UPC 80214 8 52263 30033 1

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

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.

Any adverse events that may be related to the use of this product should be reported 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].

Nutracoastal Trading LLC, a Delaware Limited Liability Company, is committed to providing accurate information about its products because of concerns for the health and safety of consumers. Nutracoastal Trading LLC is working voluntarily with the FDA in the recall process. It sincerely regrets any inconvenience to customers.

Consumers should return any unused product to the retail location where they were purchased or contact Nutracoastal Trading LLC directly at 866-803-2434 Monday - Friday, 9 am to 5 pm EDT.

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Nature & Health Co. Issues Voluntary Nationwide Recall of Six Male Enhancement Products Marketed as Dietary Supplements

Opteron 1 Inc. dba Nature & Health Co., announced today that it is conducting a voluntary nationwide recall of the company's five supplement products sold under the following names: LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsule, Herbal Disiac.

The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of these five samples found they contains either tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED) , its analog aminotadalafil, or the analog of sidenafil, an active ingredient of another FDA-approved ED drug, making these products unapproved drugs. None of the active drug ingredients are listed on the product labels. The undeclared 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. Additionally, the product may cause side effects, such as headaches and flushing.

The six recalled products listed below were distributed in retail stores in California, Georgia, Illinois, Texas, and Ohio.
Brand Size Active Pharmaceutical Ingredient
LibieXtreme 1 Capsule Packet Aminotadafil
Y-4ever 1 Capsule Packet Sulfoaidenafil
Libimax X Liquid 1 Fl. Oz. Packet Aminotadafil
Powermania liquid 1 Fl. Oz. Packet Sulfoaidenafil
Herbal Disiac 40 capsule bottle Tadalafil
Powermania 1 Capsule Packet Sulfoaidenafil

Customers who have these products in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.

Any adverse events that may be related to the use of this product should be reported 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 these products.

Consumers should return any unused products, for a refund of the full purchase price or price for the unused portion, to the retail location where they were purchased or contact Nature & Health directly at (714) 671-0016Monday – Friday, 8am to 5pm or by email at sales@naturenhealth.com to receive further instructions for returning the product or with any questions.

Hi-Tech Pharmaceuticals, Inc. Issues Nationwide Recall of All Lots of Stamina-Rx Dietary Supplement Products

Hi-Tech Pharmaceuticals, Inc. (“Hi-Tech”), 6015-B Unity Dr., Norcross, GA 30071, announced today that it is conducting a nationwide voluntary recall of the company's product sold under the name Stamina-Rx.

On May 1, 2009, Hi-Tech was notified by the Food and Drug Administration (FDA) that FDA's lab analysis of one lot of Stamina-Rx samples found that the product contained the undeclared ingredient − benzamidenafil − a Phosphodiesterase Type 5 (PDE5) inhibitor. The lot number found to contain benzamidenafil is Lot 08141578, Exp. 9/10. Benzamidenafil is in the same therapeutic class of active pharmaceutical ingredients that include the PDE5 inhibitors sildenafil, tadalafil, and vardenafil, that are FDA-approved for the treatment of erectile dysfunction (ED). Benzamidenafil is not FDA-approved, and poses a threat to consumers because benzamidenafil 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 and may be most susceptible to adverse effects from this product.

Stamina-Rx is sold predominantly in health food and drug stores nationwide. The product is sold in 10, 30, and 40-tablet bottles and in 2 and 6-tablet blister packs.

In addition to the one lot described above, Hi-Tech is recalling all other lots of Stamina-Rx because it is an unapproved new drug and misbranded new drug in violation of the Federal Food, Drug and Cosmetic Act (the Act). FDA notified Hi-Tech that, based on certain labeling claims made by the firm, Stamina-Rx is a drug as defined in the Act. Stamina-Rx is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. The labeling at issue was not on bottles of Stamina-Rx, but was contained in certain web-based and print media.

Hi-Tech has been under a Consent Decree of Permanent Injunction with FDA since September 23, 2003. In accordance with the Decree, FDA determined that additional corrective actions were necessary for Hi-Tech to achieve compliance with the Act and the Decree and therefore, on May 1, 2009 FDA ordered Hi-Tech to recall all lots of Stamina-Rx to the consumer level.

Customers who have this product in their possession should stop using it immediately. Any adverse events that may be related to the use of this product should be reported to Hi-Tech Pharmaceuticals, Inc., Norcross, GA 30071 at toll-free 1-888-855-7919 from 9:00 AM - 5:00 PM EST.

The public is encouraged to submit a report of any serious adverse events that occur with the use of Stamina-Rx to FDA’s MedWatch Adverse Event Reporting program online at [www.fda.gov/MedWatch/report.htm] or 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 20853-9787 or fax [1-800-FDA-0178].

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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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