J & H Besta Corp. of Hicksville, NY, has been informed by the Food and Drug Administration (FDA) that FDA lab analysis of Slim-30 Herb Supplement Lot 6032101 distributed by the company was found to contain undeclared Desmethyl Sibutramine, similar in structure to Sibutramine. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss. The FDA has not approved Slim-30 Herbal Supplement, therefore the safety and effectiveness of the product is unknown. On July 16, 2010, J & H Besta had recalled Lot/Code 032009 and is now expanding the recall action to include Lot 6032101.
FDA advises that this product poses 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.
Slim-30 Herb Supplement is marketed as a Natural Herb for Weight Loss. Slim-30 Herb Supplement is packaged in plastic bottles containing 30 capsules per bottle and bears UPC 8 31457 005009 2.
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. This recall is being conducted with the knowledge of the FDA.
J & H Besta Corp. is taking this voluntary action because of the concern for the health and safety of consumers. The company is discontinuing distribution of Lot/Code 6032101. It sincerely regrets any inconvenience to our customers.
Consumers should not consume Slim-30 Herb Supplement and should return it immediately to the place of purchase for a full refund. Consumers with questions should contact Jason Wang at 516-735-1436, Monday - Friday, 10:00 am - 5:30 pm, EDT.
Any adverse reactions experienced with the use of this product may be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm9], by phone 1-800-332-1088 [1-800-FDA-1088], or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms10" page], by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178].
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Thursday, August 19, 2010
J & H Besta Expands Nationwide Recall of Slim- 30 Herb Supplement to Include Lot 6032101 Found to Contain an Undeclared Drug Ingredient
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Tuesday, July 20, 2010
J & H Besta Corp. Issues a Voluntary Nationwide Recall of Slim- 30 Herb Supplement Found to Contain an Undeclared Drug Ingredient
J & H Besta Corp. of Hicksville, NY, has been informed by the Food and Drug Administration (FDA) that FDA lab analysis of Slim-30 Herb Supplement distributed by the company was found to contain undeclared N-Desmethyl Sibutramine and traces of Sibutramine. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss. The FDA has not approved this product, therefore the safety and effectiveness of the product is unknown.
FDA advises that this product poses 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.
Slim-30 Herb Supplement is marketed as a Natural Herb for Weight Loss. Slim-30 Herb Supplement is packaged in plastic bottles containing 30 capsules per bottle and bears UPC 8 31457 005009 2. The affected lot/code being recalled is 032009. The product was sold to distributors and retail stores nationwide and China and via internet sales.
No illnesses or injuries have been reported to the company to date in connection with this product.
J &H Besta Corp. is taking this voluntary action because of the concern for the health and safety of consumers. The company has discontinued distribution of this affected product lot. It sincerely regrets any inconvenience to our customers.
Consumers should not consume the Slim-30 Herb Supplement and should return it immediately to the place of purchase for a full refund. Consumers with questions should contact Jason Wang at 516-735-1436, Monday through Friday, 10:00 am to 5:30 pm, EDT.
Any adverse reactions experienced with the use of this product may be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online [at www.fda.gov/MedWatch/report.htm9], by phone 1-800-332-1088 [1-800-FDA-1088], or by returning the postage-paid FDA form 3500 [which may be downloaded from the MedWatch "Download Forms10" page], by mail [to address on the pre-addressed form] or fax [1-800-FDA-0178].
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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Wednesday, June 23, 2010
United Pet Group Voluntarily Recalls Pro-Pet Adult Daily Vitamin Supplement for Dogs Because of Possible Salmonella Health Risk
United Pet Group, Cincinnati, Ohio is voluntarily recalling all unexpired lots of its PRO-PET ADULT DAILY VITAMIN Supplement tablets for Dogs due to possible Salmonella contamination. The Food and Drug Administration is aware of this recall.
The product was sold nationally at various retailers. The product comes in 100-count white plastic bottles with a light blue label, and UPC code 26851-01800. These products are being removed from retail stores and consumers should immediately stop feeding these supplements to their pets. The affected products are those with expiration dates on or before "06/13". The expiration date can be found imprinted vertically on the right side of the product label.
Laboratory testing has revealed that one Lot of this vitamin product was contaminated with Salmonella. The company is recalling all unexpired Lots of the product out of an abundance of caution.
Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.
People who handle dry pet food and/or treats can become infected with Salmonella, especially if they have not thoroughly washed their hands after having contact with the chews or any surfaces exposed to these products. Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.
Consumers who have purchased the product are urged to contact United Pet Group or the place of purchase for further direction. Consumers may contact United Pet Group at 1-800-645-5154 ext. 3, Monday through Friday, from 8:30 am to 5:00 pm EST.
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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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Monday, August 24, 2009
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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Wednesday, July 15, 2009
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.
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Thursday, March 19, 2009
Bodee LLC, Issues A Voluntary Nationwide Recall of Zencore Plus, a Product Marketed as a Dietary Supplement
Bodee LLC, 2222 Avenue of the Stars, 702E, Century City, CA 90067, announced today that it is conducting a nationwide voluntary recall of all the company's supplement product sold under the name Zencore Plus.
Bodee LLC is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Zencore Plus samples found the product contains benzamidenafil which is a newly discovered PDE5 inhibitor. Although different in structure, benzamidenafil is likely to have the same pharmacological properties as the other three PDE5 inhibitors, sildenafil, tadalafil and vardenafil, which are the active ingredients of three FDA approved drugs for Erectile Dysfunction (ED). Zencore Plus does not contain any of these three active ingredients. The use of Zencore Plus by an unsuspecting user of organic nitrates may pose a life-threatening risk of sudden and profound drop of blood pressure due to potential interaction between benzamidenafil and organic nitrates. The probability of this occurrence is unknown; therefore, it may cause a public health risk when used as a dietary supplement.
Zencore Plus is sold in health food stores and by mail order on internet nationwide. The Zencore Plus product is sold as a 2-capsule blister pack packaged in a retail booklet with five booklets in a box or as a 10-capsule blister pack in a retail box. The capsules were supplied by Hi-Tech Pharmaceuticals, Inc., Norcross, GA.
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 the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
Consumers with questions may contact Bodee LLC Monday through Friday 8:00 am to 5:00 pm at (800) 935-0296 or help@zencoreplus.com. Bodee LLC is taking this voluntary action because it is committed and is always concerned with the health of persons who have consumed this product. The Company is reviewing the procedures and policies of all firms involved with the manufacture of the product to prevent recurrence of these issues. It is working closely with the FDA in the recall process and is committed to the quality and integrity of its products. It sincerely regrets any inconvenience to consumers and its other customers.
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Wednesday, November 26, 2008
Balanced Health Products, Inc. Conducts Voluntary Urgent Nationwide Recall of Starcaps Dietary Supplement Capsules Found to Contain an Undeclared Drug
Balanced Health Products, Inc. Conducts Voluntary Urgent Nationwide Recall of Starcaps Dietary Supplement Capsules Found to Contain an Undeclared Drug Ingredient
Balanced Health Products, Inc. is voluntarily recalling STARCAPS DIET SYSTEM DIETARY SUPPLEMENT, Lot 12/2011 – 84810, sold in 30 capsule plastic bottles.
The recall is effective immediately and is being undertaken because this lot of STARCAPS contains an undeclared drug ingredient- Bumetanide – a diuretic available by prescription only. Bumetanide is also not listed on the product label as an ingredient in this product.
Bumetanide is a diuretic indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease including nephrotic syndrome. Bumetanide has been detected in STARCAPS at a level of 0.8mg per capsule. Potential risks associated with the use of Bumetanide include serious and significant fluid and electrolyte loss and an elevation in uric acid concentrations. Consumers should not take Bumetanide if they are allergic to sulfonamides. Significant drug interactions with Bumetanide, such as with digoxin and lithium, may lead to an increase risk of toxicity. Patients may also be at an increased risk of hypotension (low blood pressure), fainting (syncope) and resultant injury if they have normal blood pressure or are already taking an antihypertensive medication and take STARCAPS with undeclared Bumetanide.
The company has received no reports of illness associated with this product.
To date, this recall only applies to Lot 12/2011 – 84810. The company is in the process of testing other lots and will notify the FDA of its results, as well as, if additional lots are to be recalled.
The recalled lot totaling 1,974 consumer-size bottles were distributed nationwide from August 2008 to October 30, 2008 through retail outlets and online sales.
Consumers who purchased STARCAPS Lot 12/2011 – 84810 should immediately discontinue their use and return it to Balanced Health Products, Inc at the address on the product label.
Consumers with questions may contact the company at (212) 794-9793 from 10:30am to 4pm EST Monday through Friday.
Consumers who experience adverse events with any lots of this product should seek immediate help from their physician or healthcare provider.
Retail stores are being notified by fax or registered mail to immediately stop all sales and return product to the company.
This recall is being made in cooperation with the US Food and Drug Administration.
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, HF-410, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at wwww.fda.gov/medwatch.
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Monday, July 28, 2008
Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of all Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules
Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of all Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules, Products Marketed as Dietary Supplements, Containing an Undeclared Ingredient
Jack Distribution, LLC, 1501 Green Road Unit C Pompano Beach, Florida 33064 and its wholesale distributors G & N works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of all lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. New lots of Rize 2 and Rose 4 her (not subject to this recall) will contain lot numbers beginning in "BL".
Jack Distribution, LLC, is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Rize 2 and Rose 4 Her samples of random lots found the product contains potentially harmful, undeclared ingredients. FDA asserts that its chemical analysis revealed that Rize 2 The Occasion and Rose 4 Her contain thiomethisosildenafil, an analog of sildenafil, the active ingredient of a FDA-approved drug used for Erectile Dysfunction (ED). FDA maintains that this ingredient is close in structure to sildenafil and is expected to possess a similar pharmacological and adverse event profile. This undeclared chemical poses a potential threat to consumers because it 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.
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 Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
The company advises that any unused portions can be returned to the place of purchase for a full refund of purchase price. Jack Distribution will manufacture new lots of these products which are not subject to the recall. Those lot numbers will begin with "BL" and will begin to be sold shortly.
Rize 2 and Rose 4 Her are sold in adult stores, vitamin & nutrition shops, convenience stores, and via the internet nationwide. The Rize 2 product is sold as a (single blister pack, three count bottles, twelve count bottles, and thirty count bottles. Rose 4 Her is only available in single blister packs and three count bottles.
The Company is taking this voluntary action because it is committed and is always concerned with the health of persons who have consumed this product. The Company is reviewing the procedures and policies of all firms involved with the manufacture of the product to ensure that there will be no future issues with regard to Rize 2 and Rose 4 Her pills composition. The Company is working closely with the FDA in the recall process and is committed to the quality and integrity of its products. It sincerely regrets any inconvenience to consumers and its other customers.
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