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FDA's MedWatch Safety Alerts for Consumers: March 2016

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Apexxx and Opal by Nuway Distributors

Nuway Distributors LLC recalled all lots of Apexxx tablets, marketed as a dietary supplement for male sexual enhancement, because they contain an undeclared drug. Apexxx contains sildenafil, which is not listed on the product labels. Nuway Distributors has also announced it is removing all lots of Opal tablets to the consumer level because this product is sourced by the same vendors as Apexxx.

Risk: People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Sildenafil can interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels and be life-threatening.

Recommendations:

Stop using these products. To return the products or for help with this recall, contact Nuway Distributors at nuwaydistributors@gmail.com or by calling 407-722-0061. Contact your health care provider if you have any problems related to these products.

For more information:

[12/23/2015 - Press Release - Nuway Distributors]

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La’ Trim Plus, Jenesis and Oasis by BeeXtreme

BeeXtreme LLC recalled all lots of La’ Trim Plus, Jenesis and Oasis because they contain undeclared drug ingredients. These products are marketed as dietary supplements but contain the drug ingredients sibutramine and phenolphthalein.

Risk: Sibutramine and phenolphthalein pose a significant health hazard. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in 2010. It substantially increases blood pressure and/or pulse rate in some patients, and may present a significant risk for people with coronary artery disease, congestive heart failure, arrhythmias or stroke. Phenolphthalein is not approved for marketing in the U.S. It can cause serious gastrointestinal disturbances, irregular heartbeat, and cancer.

Recommendations:

Stop using these products. To return the products or for help with this recall, email beextremellc@gmail.comor call 814-771-4377.

For more information:

[12/23/2015 - Press Release - BeeXtreme LLC]

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Bee Extremely Amazed Weight Loss Products

Bee Extremely Amazed LLC recalled various products marketed for weight loss because they contain undeclared drugs, including sibutramine and phenolphthalein. The recalled products were sold nationwide between April 29, 2014, and Dec. 17, 2015, by mail and online.

Risk: Sibutramine and phenolphthalein pose a significant health hazard. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in 2010. It substantially increases blood pressure and/or pulse rate in some patients, and may present a significant risk for people with coronary artery disease, congestive heart failure, arrhythmias or stroke. Phenolphthalein is not approved for marketing in the U.S. It can cause serious gastrointestinal disturbances, irregular heartbeat, and cancer.

Recommendations:

Stop using these products immediately. Return them to Bee Extremely Amazed, 85205 Sportsmans Club Rd., Jewett, OH, 43986. For questions with this recall, contact Bee Extremely Amazed at sales@beeextremelyamazed.com or 844-427-6553 from 8 am to 4 p.m. EST Monday through Friday. Contact your health care provider if you have any problems related to these products.

For more information:

[12/22/2015 - Press Release - Bee Extremely Amazed LLC]

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Risk of Eye and Skin Injuries From Laser Pointers

FDA is reminding consumers about the risk of eye and skin injuries from exposure to laser products. Although most toys with lasers are safe and comply with performance standards, some products—such as hand-held laser pointers—are being misused as toys.

Risk: Lasers can cause irreversible eye injury and can irritate or even burn the skin.

Recommendations:

The FDA recognizes that there are legitimate uses of laser pointers, including giving presentations and pointing to stars. However, even lasers under the 5 milliwatts (mW) limit can cause harm if not used properly. Learn about laser safety in this FDA videodisclaimer icon. The FDA recommends the following:

  • Don’t buy laser pointers for children or allow kids to use them. These products are not toys.
  • Don’t buy any laser pointer that emits more than 5 mW power and does not have the power printed somewhere on the pointer or its packaging. Handheld laser pointers over 5 mW and those that are not properly labeled are illegal and potentially dangerous.
  • Never aim or shine a laser beam directly at any person, pet, vehicle, or aircraft. The startling effect and temporary flash-blinding from a bright beam of light can cause serious accidents.
  • Don’t aim a laser at any reflective or shiny surface, such as a mirror, where the beam cannot be controlled.
  • Check the label of your laser pointer. If it has a power greater than 5 mW, dispose of it safely according to local environmental protection guidelines.
  • In the event of injury, immediately consult your eye doctor. Laser eye injuries are likely to be painless.

For more information:

[12/22/2015 - FDA Safety Communication - FDA]

[12/16/2010 - FDA Safety Notification - FDA]

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Smart Lipo (Marketed as a Dietary Supplement)

SmartLipo365 recalled all lots of its Smart Lipo product. The product is marketed as a dietary supplement but contains the undeclared drug ingredients sibutramine, desmethylsibutramine and phenolphthalein. The product may interact in life-threatening ways with other medications.

Risk: Sibutramine and phenolphthalein pose a significant health hazard. Sibutramine is an appetite suppressant drug that was withdrawn from the U.S. market in 2010. It substantially increases blood pressure and/or pulse rate in some patients, and may present a significant risk for people with coronary artery disease, congestive heart failure, arrhythmias or stroke. Phenolphthalein is not approved for marketing in the U.S. Long-term phenolphthalein consumption could cause serious gastrointestinal disturbances, irregular heartbeat, and cancer.

The recalled products include all expiration dates and were sold in stores, Centro Naturista in Richardson, TX, and SmartLipo365 in Arlington, TX. The products were also distributed nationwide via www.smartlipo365.com.

Recommendations:

Stop using these products. For questions about this recall, call SmartLipo365 at 972-757-8136 from 10 a.m. to 5 p.m. CST Monday through Friday. Contact your health care provider if you have any problems related to these products.

For more information:

[12/18/2015 - Press Release - SmartLipo365]

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Pink Bikini (Marketed as a Dietary Supplement)

Lucy’s Weight Loss System recalled all lots of Pink Bikini White powder capsules. The weight loss product marketed as a dietary supplement contains undeclared diclofenac.

Risk: Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID), and can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Taking diclofenac during the last three months of pregnancy may harm the fetus.

The recalled product has the expiration date of July 30, 2017, and was distributed nationwide via PinkBikini.BigCartel.com and Waisted With Lucy retail store.

Recommendations:

Stop using this product. For questions about this recall and to return the product, contact Lucy’s Weight Loss System at pbfitme@gmail.com or by calling 682-308-0199 between 10 a.m. and 5:30 p.m. CST Monday through Friday.

For more information:

[12/09/2015 - Press Release - Lucy's Weight Loss System]

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Lipo Escultura Weight Loss (Marketed as a Dietary Supplement)

Lipo Escultura Corp. of Brooklyn, NY, recalled all Lipo Escultura weight loss products. These products are marketed as dietary supplements but contain the drug ingredients sibutramine and diclofenac.

Risk: Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID), and can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Taking diclofenac during the last three months of pregnancy may harm the fetus. Sibutramine also poses a significant health hazard. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in 2010. It substantially increases blood pressure and/or pulse rate in some patients, and may present a significant risk for people with coronary artery disease, congestive heart failure, arrhythmias or stroke.

Lipo Escultura products were sold and distributed nationwide by JAT Productos Naturales Corp. online at www.lipoesculturatreatment.com and through Lipo Escultura Corp.

Recommendations:

Stop using these products. For questions about this recall, call Julio Tapia at 718- 415-2611 or 347-867-9988 between 9 a.m. and 5 p.m. EST Monday through Friday.

For more information:

[12/03/2015 - Press Release - Lipo Escultura]

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Digital Temple Thermometer May Give Inaccurate Readings

Bestmed LLC recalled the Digital Temple Thermometer Model No. KD-2201 manufactured by K-Jump Health Co. Because of a manufacturing problem, some thermometers display inaccurate temperatures.

Risk: Users might receive inaccurate information and not obtain or receive the right care.

The recalled products have lot numbers 3612 through 3715 and were sold between October 2012 and November 2015. They were sold in stores under the labels: Bestmed, Good Neighbor, Kroger, Medline, Meijer, Premier Value, Safeway, Life Brand, Target, Top Care, Best Choice (Value Merchandise), and Western Family.

Recommendations:

Stop using the thermometer. For questions or to return/replace the thermometer, contact Bestmed by calling 877-299-6700, faxing 303-271-0163, or emailing DTTRecall@bestmedusa.com.

For more information:

[11/30/2015 - Press Release - Bestmed, LLC]

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Compounded Multivitamins by Glades Drugs

Glades Drugs in Pahokee, FL, voluntary recalled compounded multivitamin capsules containing high amounts of vitamin D3 (cholecalciferol). FDA has received reports of several adverse events potentially associated with these capsules. Consumption of this product may result in vitamin D toxicity, which could be life-threatening.

Risk: Patients suffering from high vitamin D levels might not initially show symptoms, which include confusion, increased urination, increased thirst, loss of appetite, vomiting, and muscle weakness.

Recommendations:

Stop taking these capsules and immediately seek medical attention.

For more information:

[11/25/2015 - Recall Notice - FDA]

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Contrast Dyes for Medical Imaging: Drug Safety Communication

Rare cases of underactive thyroid have been reported in infants after the use of contrast media containing iodine (“contrast dye”) for X-rays and other medical imaging procedures. In all the reported cases, the infants were either premature or had other serious underlying medical conditions.

Risk: FDA believes this rare occurrence is usually temporary, doesn’t require treatment and has no lasting effects.

Recommendations:

Contact your baby’s health care professional for more information or if you have questions. Infants typically do not show any visible signs of underactive thyroid.

For more information:

[11/17/2015 - Drug Safety Communication - FDA] en Español

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Auvi-Q Epinephrine Auto-injector

Sanofi US recalled all Auvi-Q (epinephrine injection, USP), including lot numbers 2299596 through 3037230, which expire March 2016 through December 2016. The product’s dosage might be inaccurate.

Risk: Patients have described symptoms of the underlying hypersensitivity reaction. If a patient experiencing a serious allergic reaction (anaphylaxis) doesn’t receive the intended dose, there could be significant health consequences, including death.

Recommendations:

Contact your health care provider for a prescription for an alternate epinephrine auto-injector. In the event of a life-threatening allergic reaction, patients should use their Auvi-Q device only if another epinephrine auto-injector is not available, and then call 911 or other medical emergency services. Contact your health care provider if you have any problems related to these products.

For more information:

[10/28/2015 - Press Release - Sanofi]

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Viekira Pak and Technivie Hepatitis C Treatments: Drug Safety Communication

The hepatitis C treatments Viekira Pak and Technivie can cause serious liver injury, mostly in patients with underlying advanced liver disease. FDA is requiring the manufacturer to include information about liver injury in the drug labels.

Risk: Some patients with underlying liver cirrhosis could have hepatic decompensation and liver failure, which might result in a liver transplant or death.

Recommendations:

Contact your health care professional immediately if you develop fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools. Don’t stop taking these medicines without first talking to your health care professional.

For more information:

[10/22/2015 - Drug Safety Communication - FDA]

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Downing Labs Recalls Sterile Compounded Products

Downing Labs LLC recalled all lots of sterile products compounded and packaged by Downing Labs because they might not be sterile. The products were distributed nationwide and in the United Kingdom between April 20, 2015, and Sept. 15, 2015.

Risk: Patients are at risk of serious infections, which may be life-threatening.

Recommendations:

Stop using the products. To return the products, contact Downing Labs at 800-914-7435 between 8:30 a.m. and 5 p.m. CST Monday through Friday, or e-mail at pharmacist@downinglabs.com.

For more information:

[10/20/2015 - Press Release - Downing Labs]

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Acetaminophen Tablets by Medline Industries Mislabeled

Medline Industries Inc. recalled lot 45810 of 500 mg acetaminophen tablets. The tablets (OTC20101) are mislabeled, displaying “Acetaminophen 325 mg” (OTC10101) instead of “Acetaminophen 500 mg.”

Risk: If the product is taken at the maximum dose, or with other medications containing acetaminophen, it may lead to liver toxicity or liver failure.

Recommendations:

Stop using the product and return it to Medline Industries.

For more information:

[10/09/2015 - Press Release - Medline Industries]

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US Compounding Recalls Sterile Compounded Products

US Compounding Inc. recalled all lots of sterile products aseptically compounded and packaged by USC because they might not be sterile. The products were distributed nationwide between March 14, 2015, and Sept. 9, 2015.

Risk: Patients are at risk of serious infections, which may be life-threatening.

Recommendations:

Stop using the products. To return the products, contact USC at 800-718-3588 Ext. 254 or 501-327-1222 Ext. 254 between 8:30 a.m. and 5 p.m. CST time Monday-Friday, or e-mail questions@uscompounding.com.

For more information:

[09/24/2015 - Press Release - US Compounding]

[09/24/2015 - List of Products Recalled - US Compounding]

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Ayurvedic by Shree Baidyanath (Marketed as a Dietary Supplement)

Shree Baidyanath brand Ayurvedic contains high levels of lead and/or mercury, which can cause serious health problems. The product is manufactured by Shree Baidyanath Ayurved Bhawan in India and sold in the United States at retail stores and online.

Risk: Excessive exposure to mercury can cause kidney or gastrointestinal problems, neurological problems, birth defects or death. Some signs of mercury poisoning include loss of coordination, vision or hearing, muscle weakness, and “pins and needles” sensations in the hands, feet and around the mouth.

Recommendations:

Stop taking this product immediately and consult your health care provider. Even if you have no symptoms and feel well, you could have high levels of lead or mercury in your body. If you have any problems related to this product, seek immediate medical care or advice from a poison control center.

For more information:

[09/17/2015 - Consumer Advice Notice - FDA]

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Miracle Diet 30 and Miracle Rock 48 (Marketed as Dietary Supplements)

One Minute Miracle Inc. recalled all lots of Miracle Diet 30 and Miracle Rock 48 (marketed as dietary supplements), which contain undeclared ingredients. Miracle Diet 30 contains phenolphthalein. Miracle Rock 48 has thiosildenafil, which is chemically similar to a drug for male sexual enhancement.

Risk: Phenolphthalein was removed from the market because of concerns of carcinogenicity. Long-term phenolphthalein consumption could cause serious gastrointestinal disturbances, irregular heartbeat, and cancer.

Using thiosildenafil with drugs that contain nitrates could cause a sudden and significant drop in blood pressure, which might be life-threatening.

Recommendations:

Stop using these products immediately.

For more information:

[09/11/2015 - Firm Press Release - The One Minute Miracle Inc.]

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OmniPod (Pod) Insulin Management System

Insulet Corp. recalled the OmniPod (Pod) Insulin Management System because it can fail. The product was distributed in September 2015. See the press release for a list of recalled lots.

Risk: Patients might not receive the correct dose of insulin, resulting in hyperglycemia and diabetic ketoacidosis.

Recommendations:

Return the product for a replacement. If you have questions, call the company at 1-855-407-3729.

For more information:

[12/23/2015 - Recall Notice - FDA]

[12/01/2015 - Press Release - Insulet Corp.]

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

March 15, 2016

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Page Last Updated: 03/15/2016
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