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Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010.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

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

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.

Male Vitality and weight loss product recalled

Blue Square Market Inc. of North Huntingdon, PA, is recalling "Kaboom Actions Strip 12 Pack" and LiDa DaiDaiHua to the user level after FDA analysis revealed the products contain undeclared active pharmaceutical ingredients. Kaboom was found to contain sulfoaildenafil and LiDa DaiDaiHua was found to contain sibutramine and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 due to increased risk of heart attacks and strokes. 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. Sulfoaildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) which could lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established. At this time, no illnesses or injuries have been reported to Blue Square Market Inc. in connection with these products.

Kaboom Actions Strips are marketed for men’s vitality and LiDa DaiDaiHua is marketed for weight loss. Kaboom Actions Strips was purchased from the manufacturer Nutrology USA, LLC. Kaboom Action Strips comes in packages of 12 strips in a black box with a picture of the strip on the front of the box and a stamped expiration date of 9/17 on the box. LiDa DaiDaiHua was purchased from the manufacturer Green Cross Store. LiDa DaiDaiHua comes in a light green and grey box with a picture of a woman on the front, with a stamped expiration date of 1/17 on the bottom.

Blue Square Market’s online store, www.calcompnutrition.com was one of many that sold these retail products. Blue Square Market is neither the manufacturer nor the distributor of the product, only a retailer. Blue Square Market has pulled all of Kaboom Actions Strip 12 Pack and Lida DaiDaiHua from its online store, calcompnutrition.com, and will no longer carry this product line.

Blue Square Market is notifying its customers by letter and is arranging for return and refund of all recalled products. Consumers who have purchased Kaboom Actions Strip 12 Pack from March 20, 2015 to July 7, 2015 with expiration date of 9/17 or Lida DaiDaiHua from Feb 23, 2015 to May 7, 2015 with expiration date of 1/17 should immediately discontinue use and return them to Blue Square Market, Inc. for a full refund.

Consumers with questions regarding this recall can contact Blue Square market by phone at 1-877-919-9992 Monday - Friday from 9am to 4:30pm 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.

• 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

Akttive High Performance Fat Burner Gold capsules recalled

Life & More, L.L.C. is voluntarily recalling 783 Bottles from Lot #000185004400 Akttive High Performance Fat Burner Gold capsules weight loss supplements. The firm was informed by the US Food and Drug Administration (FDA) that a sample of Akttive High Performance Fat Burner Gold capsules was found to contain Sibutramine, desmethylsibutramine, and Phenolphthalein.

Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 (due to increased risk of seizures, heart attacks, arrhythmia and strokes). Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not approved for marketing in the United States. These undeclared ingredients make this product an unapproved new drug for which safety and efficacy have not been established.

Products containing Sibutramine pose a threat to consumers because Sibutramine can increase blood pressure and/or pulse rate in some patients and may present a risk for those with a history of coronary artery disease, congestive heart failure or stroke. These products may also interact in life threatening ways with other medications a consumer may be taking. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.

Akttive High Performance Fat Burner Gold weight loss supplement capsules are marketed as a dietary supplement for weight loss. Akttive High Performance Fat Burner Gold capsules are packaged in aluminum bottles containing 30 gold capsules per bottle and labeled with Lot #000185004400, UPC 859189005005, Expiration 12/17. The products were distributed from January 2012 until July 2015.

The product was sold directly to distributors and online to consumers at www.akttive.com and shipped to the following states: NV, FL, NY, AZ, MA, NJ, CA, MD, TX, VA and MI.

Life & More, L.L.C. is notifying its distributors and customers by letter and is arranging for return of all recalled products. Consumers should not consume Akttive High Performance Fat Burner Gold weight loss supplement Capsules and should return it immediately to the place of purchase.

Consumers with questions regarding this recall can contact Life & More, L.L.C. at 01157-300-487-0534 or e-mail info@akttive.com , 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.

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.

 

 

Appetite suppressant - SmartLipo365 Recalled

SmartLipo365 is voluntarily recalling 122 lots of Smart Lipo (800, 900, 950 mg) capsules, to the consumer level. FDA received samples of 800 and 900mg capsules of Smart Lipo and the lab results found the Smart Lipo products to contain undeclared sibutramine, desmethyl sibutramine, and 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.

Smart Lipo is marketed as a dietary supplement and is packaged in bottles of 30 capsules, with 22 bottles of 800 mg, 77 bottles of 900 mg, and 23 bottles of 950mg.The affected Smart Lipo products include the following expiration dates: 800mg capsules - 9/15/2017, 900mg capsules - 7/30/2017, 950 mg capsules - 7/30/2017 & 7/30/2018. Smart Lipo was sold in stores, Centro Naturista in Richardson, TX, SmartLipo365 in Arlington, TX, as well as distributed nationwide via the Internet,SmartLipo365.com

SmartLipo365 is notifying its distributors and customers by e-mail and letter and will not continue the distribution of Smart Lipo. Consumers, distributors, retailers that have Smart Lipo which is being recalled should stop using the recalled product and asked to please dispose it.

Consumers with questions regarding this recall can contact SmartLipo365 by 1-(800)-547-6365 or info@smartlipo365.com on Monday through Friday from 10 A.M. to 5 P.M. (Central time). 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 recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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.

Two Weight Loss Supplements Recalled

REFA Enterprises, LLC is voluntarily recalling one lot of each: Forever Beautiful Bee Pollen (UPC # 6333090804632), Forever Beautiful Infinity UPC # 633090804649), to the consumer level. The products have been found to contain undeclared Sibutramine or a combination of both Sibutramine and Phenolphthalein through FDA laboratory analyses. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 (due to increased risk of seizures, heart attacks, arrhythmia and strokes). 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. These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established.

Products containing sibutramine pose a threat to consumers because Sibutramine can increase blood pressure and/or pulse rate in some patients and may present a risk for those with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. These products may also interact in life threatening ways with other medications a consumer may be taking. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.

All affected products are marketed as dietary supplements for weight loss and were packaged and distributed as follows:

Forever Beautiful Bee Pollen is packaged in bottles of 60 capsules, Forever Beautiful Bee pollen was distributed via internet to consumers nationwide from July 7, 2014 – November 3, 2014.

Forever Beautiful Infinity is packaged in bottles of 60 capsules. Forever Beautiful Infinity was distributed via internet to consumers nationwide from July 7, 2014 – November 3, 2014.

REFA Enterprises, LLC is notifying its customers by email and is arranging for return of all recalled products. Consumers that have product which is being recalled should stop using and return products to REFA Enterprises, LLC.

Consumers with questions regarding this recall can contact REFA Enterprises, LLC at (757) 420-1122 Monday – Friday 12:00 p.m. – 6:00 p.m. EST or email support@fbbpshop.com.

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

Adverse reactions 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 recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Recall: Burn 7 Capsules Contain Dangerous Drug.

 Deseo Rebajar Inc., is voluntarily recalling lot #MFD: 07.18.2013 (Exp: 07.17.2015) of Burn 7 Capsules to the consumer level. The FDA laboratory analysis of this dietary supplement found theBurn 7 Capsules product to contain undeclared Sibutramine. Sibutramine was a previously approved controlled substance for the treatment of obesity that was removed from the U.S. market in October 2010 for safety reasons.

Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk to patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Sibutramine has been withdrawn from U.S marketplace. The active drug ingredient is not listed on the label for these products.

 The recalled products are packaged in 30-count plastic bottles labeled with lot number #MFD: 07.18.2013.

The product lot was sold directly to individual customers in our offices in Fajardo, Caguas and Bayamon and in website www.deseorebajar.com. We sincerely regret any inconvenience to our customers.

Consumers with questions should contact Deseo Rebajar Inc. at 787.961.6464 or via email at sales@adipotrim.com Monday - Friday, 8:00 am - 5:00 pm, [GMT time zone]. 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 events that may be related to the use of this product may be reported to 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

Deseo Rebajar Inc. is taking this voluntary action because it is committed to the health and safety of its customers and to the quality of its select brands. We are working diligently to make available appropriate natural herbal regulations. We are moving forward with new custom formula. We value our relationship with you and will continue to provide you with the best

Recall: weight Loss Supplement Contains Life Threatening Drug

B@B Trade, Inc., Florida is voluntarily recalling all lots of Slim Fortune, Lidiy, and Slim Expert to the consumer level. The FDA laboratory analysis of these dietary supplements found to contain undeclared Sibutramine. Sibutramine was a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, making these products unapproved new drugs.

These products may 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. This product may also interact, in life-threatening ways, with other medications a consumer may be taking. No illnesses or injuries have been reported to B@B Trade, Inc. to date in connection with these products.

The recalled products are packaged in plastic bottles as follows: Slim Fortune green capsules / 30 capsules per bottle, Lidiy green capsules, / 30 capsules per bottle, and Slim Expert 30 softgels capsules per bottle. All these products are marketed as a natural herb for weight loss.

The products were sold directly to individual customers in our Florida, sales office and online at www.lidiy.com, www.slimfortune.com, or www.slimexpert.com. The company has discontinued distribution and sales of these products. It sincerely regrets any inconvenience to our customers. Consumers should not consume Slim Fortune, Lidiy, or Slim Expert Dietary Supplements and should return the products immediately to the place of purchase. Consumers with questions should contact B@B Trade Inc. at 305-763-6956 or via e-mail at interincorp@yahoo.com Monday - Friday, 10:00 am - 4:00 pm, EDT.

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.

• 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