APEXXX and OPAL male enhancement supplement recalled

Nuway Distributors llc is voluntarily recalling all lots of APEXXX tablets to the consumer level. FDA analysis found APEXXX to contain amounts of the PDE-5 Inhibitor, sildenafil, which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED) making this tainted dietary supplement and unapproved drug.

Sildenafil is not listed on the product labels. Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels that may be life threatening. 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.

This product marketed as a dietary supplement for male sexual enhancement. APEXXX is packaged in a single blister pack containing 1 tablet. UPC 705105963617. All lots of APEXXX are included in this recall sold in 2014 to June 2015. APEXXX can be identified by the black packaging, it is a yellow diamond shaped tablet embosses with the wording "APEXXX" on it. APEXXX was sold in retail store located in Orlando, Florida for further sale in smoke shops, convenient stores and gas stations. APEXXX may also have been further sold online.

In an abundance of caution, Nuway Distributors llc is also removing all lots of OPAL tablets to the consumer level because this product is sourced from the same vendors as the APEXXX product. OPAL is packaged in a single blister pack containing 1 tablet, UPC 794504852400. OPAL can be identified by the black packaging, it is a black diamond-shaped tablet [note any embossing]. OPAL was also sold in a retail store located in Orlando, Florida for further sale in smoke shops, convenience stores and gas stations. OPAL may also have been further sold online.

Nuway Distributors llc is now notifying its customers by press release and is arranging for a return of all recalled and removed products.

Consumers and retailers that have APEXXX or OPAL should stop using and distributing this product immediately and arrange return of the products.

Consumers with questions regarding this voluntary recall can contact Nuway Distributors llc by email at nuwaydistributors@gmail.com and calling at 407-722-0061. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report online: www.fda.gov/medwatch/report.htm
• Regular Mail or FAX: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request reporting form, then complete and return to the address on the pre-addresses form, or submit by fax to 1-800-FDA-0178.

"As Nuway Distributors llc receives this product from overseas in a sealed package, representing that it contains only lawful and legitimate ingredients, we are relying on the representations of the Food and Drug Administration that the public interest would best be served by voluntarily complying with their request to get the product off the shelves. Our goal is to protect the safety of the consumer," stated Nuway Distributors llc.

Various Weight Loss Products are being recalled

Bee Extremely Amazed LLC, Jewett, OH is voluntarily recalling various products marketed for weight loss to the consumer level due to findings of undeclared drug ingredients including sibutramine and/or phenolphthalein.

Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. 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. Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established. These products may also interact in life-threatening ways with other medications a consumer may be taking. To date, Bee Extremely Amazed is not aware of any adverse event reports related to these products.

All lots of the following products marketed for weight loss are being recalled:

• Asset Bold Manufactured for Asset Descor 500 mg 60 capsules per bottle-color-red
• Asset Extreme Plus Manufactured for Asset Descor 500 mg 30 capsules per bottle-color-red and yellow
• Evolve Manufactured for 2637 E. Atlantic Blvd, Pompano Beach, Florida 33062 250 mg per capsule 60 capsules per bottle-color-green and white
• Infinity Manufactured for Floyd Nutrition 500 mg 30 capsules per bottle-color-red
• Jenesis Manufactured for Timeless Solutions 1810 E. Sahara Ave #100 Las Vegas, Nevada 89104 350 mg per capsule 60 capsules per bottle-color-blue
• La Trim Plus Manufactured for: MWN Health 37 N Orange Ave Suite 500 Orlando, FL 32801 (407) 930-4043 350 mg 60 Capsules
• Oasis Manufactured for MWN Health 37 N. Orange Ave Suite 500 Orlando, Fl, 32801 500 mg per capsule, 45 capsules per bottle-color-red
• Prime Manufactured for Zagonfly 3129 25th St #392 Columbus, Indiana 47203 500 mg per capsule, 60 capsules per bottle-color-red
• SlimeX-15 Manufactured in India by: HAB Pharmaceuticals & Research Limited 10-Pharma City, SIDCU?L, Selaqui, Dehradun, 248 197 15 mg 30 capsules per bottle–color-orange
• Slim Trim U Manufactured for Floyd Nutrition 250 mg 60 capsules per bottle-color-green and white
• Ultimate Formula Manufactured for Zi Xiu Tang 250 mg 48 capsules per bottle-color-green and white
• Xcel Manufactured for JNS Health 60 capsules per bottle-color-silver
• Xcel Advanced Manufactured for JNS Health 350 mg 60 capsules per bottle-color-gold
• Zi Xiu Tang 250 mg 60 capsules per bottle-color-green and white

The affected products were sold nationwide between 4/29/2014 – 12/17/2015 via distribution/resale via the U.S. Postal service with the return addressee referenced as Bee Extremely Amazed, LLC or through any association with the email addresssales@beeextremelyamazed.com and websites www.beeextremelyamazed.comwww.beefitamy.com, www.slimtrim.diet, www.Storeenvy.com.

Bee Extremely Amazed LLC is notifying its customers to stop using these products immediately and dispose of or return all recalled products to Bee Extremely Amazed 85205 Sportsmans Club Road Jewett Ohio 43986.

Consumers with questions regarding this recall can contact Bee Extremely Amazed by email to sales@beeextremelyamazed.com or 1-844-427-6553 Monday - Friday 8:00 am - 4:00 pm EST. Consumers should contact their physician or healthcare provider if they have any health questions or have experienced any problems that may be related to taking or using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Lucy's Weight Loss System Recalls Weight Loss Supplement

 Lucy's Weight Loss System is voluntarily recalling all lots distributed May 25 - June 23 2015 of Pink Bikini and Shorts on the Beach Blue and Gold Edition, 30 blue capsules (750MG per) capsules and 30 gold capsule (800MG per) capsules to the consumer level. The Pink Bikini and Shorts on the Beach have been found positive for Sibutramine and Phenolphthalein after FDA sampling and testing.

Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. 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. Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established. These products may also interact in life-threatening ways with other medications a consumer may be taking.

The product is used as a weight loss dietary supplement and is packaged in clear bottle in blue and gold. The affected Pink Bikini and Shorts on the Beach lots include the following expiration date 7/30/2017. Product was distributed nationwide to consumers via Internet.

Lucys Weight Loss System is notifying its customers by Email and is arranging for return. Consumers that have recalled Pink Bikini and Shorts on the Beach should stop using and discard.

Consumers with questions regarding this recall can contact Lucy's Weight Loss System by phone (682)-308-0199 or pbfitme@gmail.com on Monday thru Friday 10:00am to 5:30pm CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm

or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Lipo Escultura, Weight Loss Supplement,Recalled due to containing harmful ingreadients

Lipo Escultura Corp. of Brooklyn, NY dba JAT Productos Naturales Corp., and JAT Natural Products Corp. are voluntarily recalling all Lipo Escultura within expiry to the consumer level. The Lipo Escultura capsules were tested by the U.S. Food and Drug Administration and have been found to contain two potentially harmful ingredients--sibutramine and diclofenac.

Risk Statement: Sibutramine is an appetite suppressant now a controlled substance that was removed from the market for safety reasons. 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. Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). NSAIDS may cause increased risk of cardiovascular events, such as heart attack and stroked, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines.

The product is used as a weight loss dietary supplement and is packaged in a white plastic bottle with green and lime labeling with white capsules. Products were sold/distributed Nationwide by JAT Productos Naturales Corp. via internet sales on www.lipoesculturatreatment.com, through Lipo Escultura Corp. 888 Wyckoff Ave. Brooklyn, NY 11237, a retail store and 1360 Hancock Street, Brooklyn, NY 11237, a home office.

The recall was initiated after a consumer illness was reported to the FDA and it was discovered that the product labeling does not reveal the presence of sibutramine or diclofenac.

Immediately discontinue the use of this product. Consumers with questions should contact Julio Tapia at (718) 415-2611 or (347) 867-9988 Monday through Friday from 9am to 5pm Eastern Standard Time.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program  either online, by regular mail or by fax.

• Online: www.fda.gov/Safety/MedWatch/default.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

Health News: Feds announce ‘Nationwide Sweep’ of supplement makers ♦ Simple drug regimen cures hepatitis C virus in patients ♦ New fat cell metabolism research

Feds announce ‘Nationwide Sweep’ of supplement makers Seven federal agencies, led by the U.S. Department of Justice (DOJ), have announced joint civil and criminal actions against more than 100 makers and marketers of potentially dangerous dietary supplements, which one official compared to modern-day versions of “snake oil salesman and medical quacks.”

Simple drug regimen cures hepatitis C virus in patients after 12 weeks Researchers have found that a simple drug regimen delivered over 12 weeks achieved sustained eradication of several genotypes of the hepatitis C virus (HCV) in 99 per cent of the trial's patients

Emergency response system for blood formation identified inside body Scientists have determined how the body responds during times of emergency when it needs more blood cells. When tissue damage occurs, in times of excessive bleeding, or during pregnancy, a secondary, emergency blood-formation system is activated in the spleem

New fat cell metabolism research could lead to new ways to treat diabetes, obesity New insights into what nutrients fat cells metabolize to make fatty acids have been released by scientists. The findings pave the way for understanding potential irregularities in fat cell metabolism that occur in patients with diabetes and obesity and could lead to new treatments for these conditions

Natureal, a weight loss supplement was recalled

Inaffit, LLC is voluntarily recalling all lots of Natureal light green and dark green capsules to the consumer level after FDA laboratory testing found Natureal to contain sibutramine.

Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. 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. This undeclared ingredient makes this product an unapproved new drug for which safety and efficacy have not been established. This product may also interact in life-threatening ways with other medications a consumer may be taking.

The product is used as a weight loss dietary supplement and is packaged in clear bottle with light green and dark green capsules. The affected Natureal product includes lots Manufactured 3/12/2015 Expiration Date 3/11/2017 which have been distributed from the Natureal office, 14707 South Dixie Highway, Suite 213, Palmetto Bay, FL 33176 and nationwide to consumers via internet www.naturealfls.com.

Inaffit, LLC is notifying its customers by Email and is arranging for return. Consumers who are currently in possession of recalled Natureal light green and dark green capsules should stop using the product and discard. Inaffit, LLC switched to a U.S. Food and Drug Administration Registered Facility to manufacture their dietary supplements and changed the Natureal packaging to a clear bottle with clear capsules.

Consumers with questions regarding this recall can contact Inaffit, LLC by email atreturns@naturealfls.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm

or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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

Weight Loss Supplement recalled - contained Sibutramine and Phenolphthalein

System is voluntarily recalling all lots distributed May 25 - June 23 2015 of Pink Bikini and Shorts on the Beach Blue and Gold Edition, 30 blue capsules (750MG per) capsules and 30 gold capsule (800MG per) capsules to the consumer level. The Pink Bikini and Shorts on the Beach have been found positive for Sibutramine and Phenolphthalein after FDA sampling and testing.

Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. 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. Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established. These products may also interact in life-threatening ways with other medications a consumer may be taking.

Lucy's Weight Loss System has received not received any complaints to date. Lucy's Weight Loss System has not received any reports of adverse events related to this recall.

The product is used as a weight loss dietary supplement and is packaged in clear bottle in blue and gold. The affected Pink Bikini and Shorts on the Beach lots include the following expiration date 7/30/2017. Product was distributed nationwide to consumers via Internet.

Lucys Weight Loss System is notifying its customers by Email and is arranging for return. Consumers that have recalled Pink Bikini and Shorts on the Beach should stop using and discard.

Consumers with questions regarding this recall can contact Lucy's Weight Loss System by phone (682)-308-0199 or pbfitme@gmail.com on Monday thru Friday 10:00am to 5:30pm CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Weight Loss Supplement And Male Enhancement supplements recalled

The One Minute Miracle Inc. is voluntarily recalling all lots of Miracle Diet 30, capsules and Miracle Rock 48, capsules to the consumer level. These products have been recalled due to FDA analysis revealing that these dietary supplements contain undeclared drug products making them unapproved drugs.

Miracle Diet 30 has been found to contain undeclared phenolphthalein, phenolphthalein was an ingredient used in over-the counter laxatives but was removed from the market because of concerns of carcinogenicity. There is a reasonable probability that the health risks of long term phenolphthalein consumption could include serious gastrointestinal disturbances, irregular heartbeat, and cancer with long term use.

Miracle Rock 48 has been found to contain undeclared thiosildenafil, thiosildenafil is an analogue of sildenafil which is an approved drug used for the treatment of male sexual enhancement. Based on the similarity of chemical structures thiosildenafil, the analogue of sildenafil is likely to have a similar pharmacological effect as sildenafil and there is a reasonable probability that concomitant use of this dietary supplement and nitrates could cause a sudden and significant drop in blood pressure that may be life threatening.

Miracle Diet 30 capsules is marketed as a dietary supplement to support appetite control and weight loss and is packaged in 30-count plastic bottles. All lots of Miracle Diet 30 through the expiration date of 04/15/2018 are affected. Product was distributed via internet nationwide in the United States.

Miracle Rock 48 capsules is marketed as a dietary supplement for male sexual enhancement and is packaged in two blister packages of 2- count capsules, 4 capsules per box. All lots of Miracle Rock 48 through the expiration date of 06/01/2018 are affected. Product was distributed via nationwide in the United States.

In addition to the voluntary recall of the above products, The One Minute Miracle Inc. has chosen to voluntarily withdraw the following products from the marketplace to provide its customers with the certainty of safety. Those products include all sizes and lots of Miracle Cholesterol, Miracle Night Time, Miracle Joint-Flex, Miracle Stud 72, Miracle Magic Man, Male Mint Gum, Miracle 48 Hrs, Miracle Magic Woman, Miracle Cougar, Miracle Cougar Gum, Miracle Cougar G-Spot, Miracle G-Spot, Vagina Rejuvenation, Miracle Anti-Wrinkle, Miracle Stud Delay, Miracle Male Stud Spray, Miracle Male Stud Coffee, Miracle Male Coffee, Male 10, Miracle Male Stud Sublingual, Male 72 Hr, Miracle Tongue Sublingual, Miracle Tongue and Master Blaster

The One Minute Miracle is notifying its customers via U.S. Postal Service and is arranging for return of recalled products. Consumers that have Miracle Diet 30 and/or Miracle Rock 48 which are being recalled should stop using and return product(s) immediately to: The One Minute Miracle Inc. 3322 NE 166 Street, North Miami Beach, FL 33160

Consumers with questions regarding this recall can contact The One Minute Miracle Inc. by phone (305)947-6244 or emailtheoneminutemiracle@gmail.com Monday through Friday, 9:00am through 5:00pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

 

UltraZx,weight loss suppliment recalled - it contained a cancer causing drug

UltraZx, Labs, L.L.C. is voluntarily recalling “UltraZx” weight loss supplements. This product has been found to contain undeclared Sibutramine and phenolphthalein.

FDA laboratory analysis of confirmed that UltraZx contains sibutramine and phenolphthalein. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The 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. Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the United States. Studies have indicated that it presents a cancer causing risk. This product may also interact, in life-threatening ways, with other medications a consumer may be taking.

Ultra ZX LABS, L.L.C. has not received any reports of adverse events related to this recall. UltraZx weight loss supplement is marketed as a dietary supplement used as a weight loss aid and is packaged in bottles of thirty (30) capsules of 300mg. The affected UltraZx weight loss supplement, includes all lots/bottles/packages. The products were distributed from September 2014 until February 2015.

UltraZx Labs, L.L.C. is notifying its distributors and customers by letter and is arranging for return of all recalled products. Consumers and distributors that have product which is being recalled should stop using the product and return the product to UltraZx Labs, L.L.C.

Consumers with questions regarding this recall can contact UltraZx Labs, L.L.C. at (305) 904-9393, Monday through Friday from 9:00am – 5:00pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

This recall is being conducted with the knowledge of the Food and Drug Administration (FDA).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

3/3/15 Health News:Soft drink tax could improve health ♦ Disease-carrying fleas abound on New York City's rats ♦ nitrate supplementation may increase athletic performance

Soft drink tax could improve health of the nation  An excise tax on sugar-sweetened drinks would be an effective way to improve the health of heavy consumers, new research shows. Australian researchers compared the impact that a 20 per cent sales tax and a 20 cents per litre excise tax on beverages such as carbonated non-diet soft drinks, cordials and fruit drinks would have on moderate and high consumers  Continue Reading

Disease-carrying fleas abound on New York City's rats  In the first study of its kind since the 1920s, rats in New York City were found to carry a flea species capable of transmitting plague pathogens. Among them: 500-plus Oriental rat fleas, notorious for their role in transmitting the bubonic plague, also known as the Black Death  Continue Reading

Why nitrate supplementation may increase athletic performance   Walk down the aisles of any food supplement store and you'll see that the use of nitrate supplements by athletes and fitness buffs has been popular for years. The hope is that these supplements will increase endurance, and possibly other performance/health benefits, by improving the efficiency at which muscles use oxygen. Now, a research study helps explain how some of these supplements may work Continue Reading

B-Lipo Weight Loss Capsules Recalled

Bethel Nutritional Consulting, Inc. is recalling one lot of B-Lipo Capsules to the consumer level. The firm was informed by the US Food and Drug Administration (FDA) that a sample of B-Lipo Capsules collected and tested by the FDA was found to contain Lorcaserin, a controlled substance used for weight loss.

Adverse health consequences associated with taking Lorcaserin range from difficulty thinking, hallucinations, and feeling of intense excitement to changes in blood sugar and heart rate. More serious adverse events, which may be life-threatening, include damage to the heart valve, or serotonin syndrome particularly if Lipo-B is taken with other medications that work similarly. Excessive levels of serotonin can cause symptoms that range from mild (shivering and diarrhea) to severe (muscle stiffness, fever, and seizures). Severe serotonin syndrome can be fatal if not treated. No illnesses or injuries have been reported to the company to date in connection with this product.

B-Lipo Capsules are marketed as a Natural Herbal Supplement for Weight Loss. B-Lipo burgundy and white Capsules are packaged in white plastic bottles containing 30 Capsules per bottle, and labeled with Lot # 20213 EXP DATE 12/22/2016, and bar code 160126 417509.

The product was sold directly to individual customers in our New York City sales office and to consumers online atwww.bethel30.com. The company has discontinued distribution of this product.

Consumers should not consume B-Lipo Capsules and should return it immediately to the place of purchase. Consumers with questions should contact Kariny Ramirez by phone at (212) 568-5330 or via e-mail at customerservice@bethel30.com, Monday - Friday, 11:00 am - 4:00 pm, ET.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking this product.

Mayhem bodybuilding supplement Recalled

Chaotic Labz, is voluntarily conducting a nationwide recall of Mayhem dietary supplement capsules, Lot #CLM061114 with an expiration date of 06/2016, to the user/consumer level. Mayhem’s intended use is as a bodybuilding supplement. FDA laboratory analysis found that Mayhem Dietary Supplement contains undeclared dexamethasone, a prescription corticosteroid commonly used to treat inflammatory conditions, and cyproheptadine, a prescription antihistamine used for seasonal allergy treatment, making this an unapproved drug.

Consumers are advised that corticosteroid use can impair a person’s ability to fight infections, cause high blood sugar levels, muscle injuries and psychiatric problems. When corticosteroids are taken for a prolonged period, or at high doses, they can suppress the adrenal gland and cause withdrawal symptoms with abrupt discontinuation. Antihistamines may cause drowsiness and affect mental alertness. In addition, these undeclared drug ingredients in Mayhem may cause serious side effects when combined with other medications. To date, Chaotic Labz has not received reports of these adverse effects related to this recall.

Mayhem is packaged in a clear bottle with yellow capsules associated with Lot #CLM061114 with an expiration date of 06/2016. The product can be identified by the brand known as Chaotic Labz and product name Mayhem, Appetite for Construction. This product was distributed nationwide to various Nutritional Supplement Retail Outlets and via the internet.

Chaotic Labz is notifying its distributors and customers by a formal recall notification and arranging for a return of all recalled products. Distribution of Mayhem will also be halted. Consumers, Distributors, and Retailers that have any of the recalled product should STOP USING and return immediately to the place of purchase. Contact your health care professional if you have experienced any adverse effects.

Consumers with questions regarding the recall can contact Cordy Hooten, Owner of Chaotic Labz, by phone number at (479) 223-2677 or email at contact.chaoticlabz@gmail.com, Monday – Friday from 9am-5pm central standard time. No other products distributed by Chaotic Labz are subject to recall.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Recall of Reduce Weight Fruta Planta

MyNicKnaxs, LLC., located in Florida is announcing a recall of Reduce Weight Fruta Planta because the products contain an undeclared active pharmaceutical ingredient: Phenolphthalein. The FDA lab analysis of the product found Reduce Weight Fruta Planta to contain 10.2 mg of Phenolphthalein.

Phenolphthalein was once an ingredient used in over-the-counter laxatives, but because of concerns of carcinogenicity is not currently approved for marketing in the United States. This undeclared ingredient makes Reduce Weight Fruta Planta an unapproved new drug for which safety and efficacy have not been established. Consumption of this product could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.

All lots of the Reduce Weight Fruta Planta products are being recalled.

MyKnicKnaxs, LLC. has taken this voluntary action because it is committed to providing accurate information to all customers and is concerned for the health and safety of all users of Reduce Weight Fruta Planta. MyKnicKnaxs, LLC, is working with the FDA in the recall process. We sincerely regret any inconvenience the recall may cause customers.

Customers are advised to immediately discontinue use and Consumers with questions should contact mynicknaxs at 386-337-8142 or via e-mail at nicnaxs@yahoo.com Monday - Friday, 2pm - 7:00 pm, EDT.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either 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
•