Gaspari Nutrition Incorproated, 575 Prospect Street - Suite 230, Lakewood, NJ, announced today that it is conducting a voluntary nationwide recall of all Lot Codes of the company's dietary supplement product sold under the name Novedex XT, which was marketed "for increasing natural testosterone production" and contains 3,17-keto-etiocholetriene, also known as ATD, an anti-aromatase. Gaspari Nutrition is conducting this consumer level recall after being informed by representatives of the Food and Drug Administration (FDA) that 3,17-keto-etiocholetriene does not meet the definition of a dietary ingredient and therefore the product is in violation of provisions of the Federal Food, Drug, and Cosmetic Act.
Potential adverse events associated with the use of anti-aromatases could include the following: decreased rate of bone maturation and growth, decreased sperm production, infertility, aggressive behavior, adrenal insufficiency, kidney failure, and liver dysfunction. Consumers with liver, kidney, adrenal, or prostate abnormalities are at higher risk for developing adverse events. Gaspari has received no serious adverse events in over five years of marketing Novadex XT.
Novedex XT had been sold internationally and domestically, to distributors, wholesalers, retail stores and direct to consumers, but was discontinued by Gaspari Nutrition for domestic sales on October 4th 2010. The product was sold in blue bottles with a black cap, containing sixty (60) capsules.
Consumers who have Novedex XT in their possession should stop using it immediately. If consumers experience any adverse side effects due to consumption of this product, they should immediately contact a physician. Adverse reactions or quality problems experienced with the use of this product may be reported to Gaspari Nutrition and 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, preaddressed Form FDA 3500 available at www.fda.gov/MedWatch/getforms.htm
* Fax: 1-800-FDA-0178.
The Company is advising consumers who have Novedex XT to return any unused portion to the retail location from which it was purchased or if purchased directly from Gaspari Nutrition to return any unused portion to: Gaspari Nutrition Incorporated, 575 Prospect Street - Suite 230, Lakewood, NJ 08701; Attention: Novedex XT Recall. Consumers with questions regarding this recall can contact the company at 1-732-364-3777 Monday through Friday 9 AM to 5 PM, PST. Consumers who have purchased this product and have medical concerns should consult with their health care providers.
This recall is being conducted in cooperation with the U.S. Food and Drug Administration (FDA).
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Friday, October 8, 2010
Gaspari Nutrition Nutrition Issues a Voluntary Nationwide Recall of Novedex XT, a Product Marketed as a Dietary Supplement Containing ATD
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Monday, September 20, 2010
iForce Nutrition Issues a Voluntary Nationwide Recall of Reversitol a Product Marketed as a Dietary Supplement Containing ATD
Tribravus Enterprises, LLC d/b/a/ iForce Nutrition, LLC, 1305 Hot Spring Way #103, Vista CA 92081, announced today that it is conducting a voluntary nationwide recall of all Lot Codes of the company's dietary supplement product sold under the name Reversitol, which was marketed “for promoting hormonal regulation…,” and contains 6-Etioallochol-1,4-Diene-3,17-Dione, also known as ATD, an aromatase inhibitor. iForce Nutrition is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that it is FDA’s opinion that 6-Etioallochol-1,4-Diene-3,17-Dione does not meet the definition of a dietary ingredient and therefore the product is in violation of provisions of the Food, Drug and Cosmetic Act. Though it disagrees with FDA, iForce Nutrition has agreed to the recall because it had already ceased selling the product. This recall does not include iForce Nutrition’s Reversitol V2, which contains 84 capsules and does not contain 6-Etioallochol-1,4-Diene-3,17-Dione (ATD).
FDA has requested that iForce Nutrition inform consumers that adverse events associated with the use of aromatase inhibitors could include the following: decreased rate of bone maturation and growth, decreased sperm production, infertility, aggressive behavior, adrenal insufficiency, kidney failure, and liver dysfunction. Consumers with liver, kidney, adrenal, or prostate abnormalities are at higher risk for developing adverse events. iForce Nutrition has not received any adverse event reports nor are they aware of any adverse events associated with the use of these products.
Reversitol had been sold nationwide, both in retail stores and direct to consumers, but was discontinued by iForce Nutrition on December 10, 2009. The product was sold in red bottles with a white cap, containing sixty (60) capsules and was Manufactured for Distribution by Tribravus Enterprises, LLC. Although this product was discontinued nearly a year ago, it has come to the attention of iForce Nutrition that some online retailers may still have remaining inventory that they are offering for sale.
Consumers who have Reversitol in their possession should stop using it immediately. If consumers experience any adverse side effects due to consumption of this product, they should contact a physician right away. Adverse reactions or quality problems experienced with the use of this product may be reported to iForce Nutrition or 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, preaddressed Form FDA 3500 available at www.fda.gov/MedWatch/getforms.htm10or Fax: 1-800-FDA-0178.
The Company is advising consumers who have Reversitol to return any unused portion to the retail location from which it was purchased or if purchased directly from iForce Nutrition to return any unused portion to: iForce Nutrition, 1305 Hot Spring Way #103, Vista CA 92081; Attention: Reversitol Recall. Please note that this recall does not include iForce Nutrition’s Reversitol V2, which contains 84 capsules and does not contain 6-Etioallochol-1,4-Diene-3,17-Dione (ATD).
Consumers with questions regarding this recall can contact the company at 1-877-743-6460 Monday through Friday 9 AM to 5 PM, PST. Consumers who have purchased this product and have medical concerns should consult with their health care providers.
This recall is being conducted in cooperation with the U.S. Food and Drug Administration (FDA).
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Wednesday, August 25, 2010
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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Friday, July 30, 2010
Nutraloid Labs Inc. Conducts Voluntary Nationwide Recall of Two Dietary Supplements Found to Contain Undeclared Drug Ingredient
Nutraloid Labs Inc. announced today that it is conducting a voluntary nationwide recall of two dietary supplement products sold under the names: ejaculoid XXTREME and stimuloid II.
Nutraloid Labs Inc. has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis of ejaculoid XXTREME, Lot 79935, and stimuloid II, Lot 79936, by the FDA found that the products contain sulfoaildenafil, similar in structure to Sildenafil. Sildenafil is an active ingredient of an FDA-approved drug for male Erectile Dysfunction (ED), making these products unapproved drugs. 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.
The recalled products listed below were distributed in black plastic bottles to distributors and via internet sales.
| Brand Name | Size | Lot | UPC |
|---|---|---|---|
| Ejaculoid XXTREME | 30 Capsules/Bottle | 79935 12/12 | 8 04879 17868 2 |
| Stimuloid II | 30 Capsules/Bottle | 79936 12-12 | 8 04879 17867 5 |
No illnesses have been reported to the company to date in connection with these products.
Customers who have any of the above 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 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.
Nutraloid Labs Inc. is conducting this recall with the knowledge of the FDA. Consumers should return any unused product to the place of purchase or contact Nutraloid Labs Inc. directly at 1-772-291-7510, Monday – Friday, 10 am to 4 pm EDT.
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Sunday, July 4, 2010
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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Sunday, January 17, 2010
MuscleMaster.com Conducts a Voluntary Nationwide Recall of Certain Body Building Products
MuscleMaster.com, Inc. ("MuscleMaster.com") announced today that it is conducting a voluntary nationwide recall of all lots and expiration dates of the seventeen below listed dietary supplements sold between June 1, 2009 and November 17, 2009 (hereinafter "Recalled Products").
FDA informed MuscleMaster.com that it believes that the Recalled Products contain ingredients that are steroids. Specifically, FDA advised MuscleMaster.com of its concern that the Recalled Products may contain the following ingredients that are currently classified, or the FDA believes should be classified, as steroids: "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol." While MuscleMaster.com cannot independently confirm the FDA's concerns, that any one or more of the Recalled Products in fact contain these ingredients, MuscleMaster.com is undertaking this voluntary recall out of an abundance of caution and in deference to FDA’s stated concerns.
Acute liver injury is known to be a possible harmful effect of using steroid-containing products. In addition, steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death.
MuscleMaster.com is recalling the following products:
Advanced Muscle Science Dienedrone, 60 caps
Advanced Muscle Science Liquidrone, 60 ml
Anabolic Formulation M1, 4AD, 60 caps
Anabolic Formulations 1, 4 AD, 60 caps
Anabolic Xtreme Hyperdrol X2
Anabolic Xtreme 3-AD, 90 caps
BCS Labs Testra-Flex, 90 caps
Competitive Edge Labs M-Drol, 90 Caps
Competitive Edge Labs P-Plex, 90 caps
Competitive Edge Labs X-Tren, 90 caps
4Ever Fit D-Drol, 60 caps
Gaspari Novedex XT 60 Caps
Gaspari Halodrol Liquigels, 60 gels
iForce 1,4 AD BOLD 200, 60 Caps
iForce MethaDROL, 90 caps
iForce Dymethazine, 60 caps
Monster Caps, 60 caps
MuscleMaster.com has not received any complaints of illness or injury regarding these products. FDA is concerned the products may present a safety risk to consumers who ingest them. MuscleMaster.com is an internet retailer and did not manufacture or formulate these products. MuscleMaster.com’s decision to implement this recall is not, and should not be construed as, an admission that their decision to sell these products was in violation of the law. In addition it is not, and should not be construed as, an admission that these products are not in compliance with the law. This recall is solely a reflection of MuscleMaster.com’s deference to the FDA’s stated concerns with these products.
Customers who have these products in their possession should stop using them immediately and contact their physician if they have experienced any problems that may be related to using one or more of the products.
Consumers should return any unused products purchased on the Company’s site to the Company. For instructions on how to return Recalled Products please call (1-800-240-4767) or e-mail (returns@musclemaster.com) the Company.
Any adverse events that may be related to the use of the Recalled Products 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].
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Tuesday, December 15, 2009
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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Tuesday, November 17, 2009
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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Saturday, November 14, 2009
IDS Sports Conducts a Voluntary Nationwide Recall of Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs, and Ripped Tabs TR
IDS Sports announced today that it is conducting a voluntary nationwide recall of five of the company’s dietary supplement products sold under the following names: Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs, and Ripped Tabs TR.
The Food And Drug Administration (FDA) has notified IDS Sports that the recalled products contain the following undeclared substances, which FDA considers to be steroids: “Madol,” “Turinabol,” “Superdrol,” and/or “Androstenedione.”
Acute liver injury is known to be a possible harmful effect of using steroid-containing products. In addition, steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death.
The recalled products listed below were distributed in either black boxes containing blister packs of 60 capsules or white bottles with black labels containing 30 or 60 capsules.
Brand Name Size UPC Lots
Bromodrol 1 box 6 75941 00250 7 All lots
Dual Action Grow Tabs 1 box 6 75941 00252 1 All lots
Grow Tabs 1 bottle 60 capsules 6 75941 00252 1 All lots
Mass Tabs 1 bottle 30 capsules 6 75941 00149 4 Purchased during or after 4/09
Mass Tabs 1 bottle 60 capsules 6 75941 00149 4 Purchased during or after 8/09
Ripped Tabs TR 1 box 6 75941 00162 3 Purchased during or after 12/08
Ripped Tabs TR 1 bottle 60 capsules 6 75941 00162 3 Purchased during or after 12/08
Although no illnesses or adverse events have been reported to the company to date in connection with the products listed above, customers who have these products in their possession should stop using them immediately and contact their physician if they have experienced any problems that may be related to using one or more of the products. Any adverse events that may be related to the use of these products should be reported to the FDA's MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm] 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 recall and IDS Sports is cooperating with the FDA in this recall process.
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Friday, November 13, 2009
GMP Herbal Products, Inc. Issues a Voluntary Nationwide Recall of a Weight Loss Supplement Found to Contain Undeclared Drug Ingredients
GMP Herbal Products, Inc. has been informed by the Food and Drug Administration (FDA) that Pai You Guo, a weight loss dietary supplement, sold and marketed by the firm contains undeclared drug ingredients. FDA lab analyses of dietary supplements distributed by the company were found to contain undeclared sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss; and phenolphthalein, a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States. The FDA has not approved the Pai You Guo products as drug; therefore the safety and effectiveness of this product is unknown. All lots of the following Pai You Guo product are being recalled. The product is sold either in a box of 30 capsules or a bag of 10 g powder.
The products listed above were sold and distributed nationwide via the internet.
FDA advises that these products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
No illnesses or injuries have been reported to the company to date in connection with this product.
GMP Herbal Products, Inc. has taken this voluntary action because it is committed to providing accurate information about its products and because of the concern for the health and safety of consumers. GMP Herbal Products, Inc. is working with the FDA in the recall process. It sincerely regrets any inconvenience to customers.
Consumers are advised to destroy the above products or return them to the company’s address in Westminster, CA. Consumers with questions may contact GMP Herbal Products, Inc Tuesday through Saturday 11:00 am to 7:00 pm at 1-866-995-8585.
Any adverse reactions experienced with the use of this product should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at wwww.fda.gov/Safety/MedWatch/default.htm.
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Tuesday, November 3, 2009
BODYBUILDING.COM Is Conducting a Voluntary Nationwide and International Recall of 65 Dietary Supplements That May Contain Steroids
As part of its ongoing cooperation with the Food and Drug Administration ("FDA"), Bodybuilding.com, LLC (the “Company") announced today that it is conducting a voluntary nationwide and international recall of all lots and expiration dates of 65 dietary supplement products (the "Recalled Products") described on the attached list, that were sold through the Company's website, www.bodybuilding.com.
The FDA has informed the Company that it believes that the Recalled Products contain ingredients that are steroids. Specifically, the FDA has advised the Company of its concern that the Recalled Products may contain the following ingredients that are currently classified, or the FDA believes should be classified, as steroids: "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol." While the Company has not had an opportunity to independently confirm the FDA's concerns that the Recalled Products in fact contain these ingredients, the Company is undertaking this voluntary recall in an abundance of caution.
Acute liver injury is known to be a possible harmful effect of using steroid-containing products. In addition, steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death.
The Company has not received to date any reports of adverse events in connection with the Recalled Products. Because of the possible harmful effects of using products containing steroids, the Company is cooperating with the FDA to conduct a recall of the products the FDA has identified as containing steroids. Prior to agreeing to carry the Recalled Products, the Company received assurances from all of the manufacturers of the Recalled Products that these products were properly classified as dietary supplements in compliance with federal law, meaning that these products did not contain any unlawful ingredient. Customers who have any of the Recalled 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 one or more of the ingredients listed above.
Any adverse events that may be related to the use of the Recalled Products 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 postagepaid 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 Company is committed to providing accurate information about its products. The Company is working voluntarily with the FDA in this recall process.
Consumers should return any unused products purchased on the Company’s site to the Company. For instructions on how to return Recalled Products please call (1-866-236-8417) or e-mail (service@bodybuilding.com) the Company.
RECALLED PRODUCT LIST Brand Name
4Ever Fit D-Drol
Advanced Muscle Science Dienedrone
Advanced Muscle Science Liquidrone UTT
Anabolic Xtreme Hyperdrol X2
APS (aka Advanced Muscle Science) Mastavol
APS (aka Advanced Muscle Science) Revamp
APS (aka Advanced Muscle Science) Ultra Mass Stack
APS (aka Advanced Muscle Science) Ripped Stack
Better Body Sports Finadex
Black China Labs Straight Drol
Black China Labs Straight Phlexed
Body Conditioning Solutions TestraFLEX
Bjorklund Methyldrostanolone
BOSC Enterprises Epi-Tren
BOSC Enterprises Magna Drol
Chaparral Labs Epivol
Chaparral Labs Pheravol-V
Competitive Edge Labs M-Drol
Competitive Edge Labs P-Plex
Competitive Edge Labs X-tren
Diabolic Labs Epio-Plex
Diabolic Labs Finabolic 50
Diabolic Labs Revenge
Ergopharm 6-OXO
Ergopharm 6-OXO Extreme
EST (aka Engineered Sports Technology) MethAnstance
Extreme Labs Susto-Test Depot
Fizogen ON Cycle II Hardcore
G.E.T/ (Genetic Edge Technologies) SUS-500
G.E.T/ (Genetic Edge Technologies) Tren-250
Hardcore Formulations T-Roid
I Force Nutrition 1,4 AD Bold 200
I Force Dymethazine/Reversitol Combo Pack
I Force Reversitol
I Force Nutrition 17a PheraFLEX
I Force Nutrition Dymethazine
I Force Nutrition Methadrol
IDS (aka Innovative Delivery Systems) Bromodrol
IDS (aka Innovative Delivery Systems) Grow Tabs TR
IDS (aka Innovative Delivery Systems) Mass Tabs
IDS (aka Innovative Delivery Systems) Oxodrol Pro
IDS (aka Innovative Delivery Systems) Ripped Tabs TR
IDS (aka Innovative Delivery Systems) Rapid Release
Ripped Tabs
Kilo Sports Massdrol
Kilo Sports Phera-Mass
Kilo Sports Trenadrol
Monster Caps Monster Caps
Myogenix Spawn
Nutra Coastal D-Stianozol
Nutra Coastal H-Drol
Nutra Coastal MDIT
Nutra Coastal S-Drol
Nutra Coastal Trena
Performance Anabolics Methastadrol
Performance Anabolics Tri-Methyl X
Purus Labs E-pol Inslinsified
Purus Labs Nasty Mass
Rage RV2
Rage RV3
Rage RV4
Rage RV5
Redefine Nutrition Finaflex 550-XD
Redefine Nutrition Finaflex Ripped
Transform Supplements Forged Extreme Mass
Transform Supplements Forged Lean Mass
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Thursday, July 30, 2009
Nutracoastal Trading LLC conducts voluntary nationwide recall of S-DROL Dietary supplement lot 810481
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: S-DROL.
The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis by the FDA for Lot 810481 found that the product contains desoxymethyltestosterone, a steroid, making S-DROL 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 black plastic bottles to retail stores nationwide.
S-DROL 1 Bottle - 60 Tablets UPC 01 2012 810481 8 272386 000376
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 products 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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Friday, July 17, 2009
Young You Corporation Issues a Voluntary Nationwide Recall of Weight Loss Pills Found to Contain an Undeclared Drug Ingredient
Young You Corporation has been informed by the Food and Drug Administration (FDA) that four weight loss dietary supplements sold and marketed by the firm contain an undeclared drug ingredient. FDA lab analyses of dietary supplements distributed by the company were found to contain undeclared Sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss. The FDA has not approved the following products as drugs; therefore the safety and effectiveness of this product is unknown. All lots of the following dietary supplement products are being recalled:
| Brand | Size | Active Pharmaceutical Ingredient |
|---|---|---|
| Slimbionic | 30 Capsules/Box | Sibutramine |
| One Weight Loss Pill 30 capsules | 30 Capsules/Bottle | Sibutramine |
| SlimDemand Capsules | 30 Capsules/Box | Sibutramine |
| Botanical Weight Loss | 30 Capsules/Box | Sibutramine |
The products listed above were sold and distributed nationwide via the internet and at the company’s Weight Loss and Rejuvenation Center in Tarzana.
FDA advises that these products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
No illnesses or injuries have been reported to the company to date in connection with this product.
Young You Corp. has taken this voluntary action because it is committed to providing accurate information about its products and because of the concern for the health and safety of consumers. Young You Corp. is working with the FDA in the recall process. It sincerely regrets any inconvenience to customers.
Consumers are advised to destroy the above products or return them to the company’s address in Tarzana, CA. Consumers with questions may contact Young You Corp Monday through Friday 9:00 am to 5:30 pm at 818-344-3344.
Any adverse reactions experienced with the use of this product should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at wwww.fda.gov/Safety/MedWatch/default.htm.
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Wednesday, April 22, 2009
Universal ABC Beauty Supply International, Inc. Issues Voluntary Nationwide Recall of Dietary Supplement Products Found to Contain an Undeclared Drug
Universal ABC Beauty Supply International, Inc. of Brooklyn, NY, has been informed by the Food and Drug Administration (FDA) that FDA lab analyses of the dietary supplements distributed by the company were found to contain undeclared Sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss. These dietary supplements are not supposed to contain Sibutramine. The FDA has not approved these products, therefore the safety and effectiveness of these products is unknown.
FDA advises that these products pose a threat to consumers because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
All lots of the following dietary supplement products are being recalled:
PRODUCT NAME
1. ProSlim Plus, 60 capsules, bottle in box
2. 3 DAYS fit, 60 capsules, bottle in box
3. EIGHT FACTOR DIET, 60 capsules, 3 pouches/box
4. 24hours Diet, 60 capsules
5. Slim 3in1 M-18 ROYAL DIET, 90 capsules, 3 pouches/box
6. 3X SLIMMING POWER, 60 capsules, bottle in box
7. Extrim Plus 24 Hours RE-BURN Formula, 60 capsules
8. Slim 3in1 EXTRA SLIM FORMULA, 90 capsules, 3 pouches/box
9. Slim 3in1 EXTRA SLIM WAIST FORMULA, 90 capsules, 3 pouches/box
10. SLIM EXPRESS 360ยบ C
11. SLIM EXPRESS 4in1, 60 capsules, bottle in box
12. ROYAL SLIMMING FORMULA, 60 capsules, bottle/box
13. BODY CREATOR, 90 capsules, 3 pouches/box
14. Slim Waistline (labeling written in Chinese)
15. BODY SHAPING, 90 capsules, 3 pouches/box
16. PERFECT SLIM, 90 capsules, 3 pouches/box
17. Perfect Slim 100% Natural Herbal Essence
18. IMELDA Perfect Slim
19. Slim Waist Formula, 32 capsules, 2 pouches/box
20. Super Slimming, 60 capsules, bottle in box
21. 2 DAY DIET
22. Powerful Slim
23. BODY SHAPING
24. SUPER FAT BURNER, 60 capsules, bottle in box
25. SLIMMING FORMULA
26. SLIM FAST 2, 32 capsules, 2 pouches/box
27. SLIM FAST, 60 capsules, 3 pouches/box
28. Slim up, 120 capsules, bottle in box
29. 7 DAYS DIET, 60 capsules, 3 pouches/box
30. Perfect Slim Up, 60 capsules, bottle in box
31. JM Fat Reducer
32. SlimBurn
33. 21 Double SLIM
34. TRIM PLUS 2
NOTE: The above products may have various UPC numbers.
No illnesses or injuries have been reported to the company to date in connection with this product.
Universal ABC Beauty Supply International, Inc. is taking this voluntary action because it is committed to providing accurate information about its products and because of the concern for the health and safety of consumers. The company has discontinued distribution of these products. It sincerely regrets any inconvenience to customers.
Consumers should not consume the above products and should return the dietary supplements on hand to the place of purchase for a full refund or partial refund of the unused portion. Distributors should contact Sandra Tan by phone at 718-891-6888 or by e-mail at universalabc@aol.com to receive further instructions for returning the product(s). Consumers with questions should contact Sandra Tan at 718-891-6888, Monday through Friday, 12:00 pm through 6 pm, EDT.
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