October 19, 2017

Gear Isle Recalls Supplements for Undeclared Drugs

Gadget Island, dba Gear Isle, is recalling four dietary supplements because they contain sildenafil, desmethyl carbodenafil and tadalafil. Those ingredients can interact with nitrates found in some prescription drugs and can cause a life-threatening drop in blood pressure. The FDA has received adverse event report from consumers who bought these products. Gear Isle has not received any reports of adverse events. The recalled products are: Rhino 7 Platinum 5000, with UPC number 617135861224 and lot number R7-D5K1011H; Papa Zen 3000, with UPC number 718122032587 and lot number NSS050888; Fifty Shades 6000, with UPC number 4026666146056 and no lot number; and Grande X 5800, with UPC number 640793555440 and no lot number. The products are labeled as dietary supplements. They were … [Read more...]

Some Dietary Supplements Recalled for Burkholderia Contamination

The FDA is updating a recall issued earlier this month for some dietary supplements that were recalled for Burkholderia cepacia contamination. This bacteria can cause serious health problems in people with cystic fibrosis and other lung diseases. Symptoms of the infection include cough, congestion, and difficulty breathing. The original recall notice stated that there have been several adverse event reports of this infection in patients that may be linked to PharmaTech LLC manufactured Diocto Syrup or Diocto Liquid. Rugby Laboratories issued a recall of those products in early August, and the three distribution firms are recalling all lots within expiry of all liquid products manufactured by PharmaTech LLC. You can see all of the recalled products, along with package sizes, product … [Read more...]

FDA Warns Consumers About Health Risks of Herbal Coffee Products from Malaysia

The Food and Drug Administration (FDA) is warning consumers not to drink Longjack Coffee, in addition to other instant coffee products that have been recalled recently. These products are made in Malaysia and are promoted and sold online for sexual enhancement. They contain undeclared drugs that can be deadly. The other products the FDA is warning about include Kopi Jantan Tradisional Natural Herbs Coffee, CaverFlo Coffee, and AMPT Coffee. They are labeled to contain instant coffee, non-dairy creamer, and other ingredients. But CaverFlo Coffee and AMPT Coffee contain undeclared sildenafil and tadalafil. And Longjack Coffee and Kopi Jantan Tradisional Natural Herbs Coffee contain desmethyl carbondenafil, an analogue of sildenafil. Those are prescription drugs and are not sold over the … [Read more...]

AMPT Coffee Recalled for Undeclared Drugs and Milk

The AMPT Life is voluntarily recalling all lots of AMPT Coffee because they contain Sildenafil and Tadalafil, the active ingredients in Viagra. AMPT Coffee also contains undeclared milk, one of the major food allergens. Those drugs can interact with nitrates found in some prescription drugs, and may lower blood pressure to dangerous levels. And anyone who cannot consume milk could have a serious reaction if they eat this product. No adverse reactions have been reported to date. AMPT Coffee is packaged in a red box and red packets with black writing. The UPC number is 6942630912. The AMPT Life, LLC distributed this product from April, 2016 through March, 2017.  AMPT Coffee is consumed as an instant coffee. It was distributed nationwide to consumers through internet sales. If you … [Read more...]

Man of Steel Recalling Supplements for Undeclared Drug

Man of Steel is voluntarily recalling 175 lots of Man of Steel 1 and Man of Steel 2 because they contain undeclared Sildenafil. The FDA has issued a risk statement, "The product has/potentially could result in death. The groups affected are men with diabetes, high blood pressure, high cholesterol, or heart disease. Man of Steel has received reports from the FDA lab but not received any reports of adverse events related to this recall." The product is packaged in an individual blister package. The capsules are 4000 mg. The expiration dates of the recalled products are 10-17-18. It was distributed throughout local convenience stores in Sacramento, California. Two other advisories about these products were issued by the FDA on June 22, 2017. Sildenafil is the active ingredient in … [Read more...]

La Bri’s Body Health Supplements Recalled for Sibutramine

EZ Weight Loss TX is recalling all lots of La Bri's Body Health Atwomic and Xplode capsules because they contain sibutramine. That compound was banned from the U.S. in October 2010 beaus it increases blood pressure and/or pulse rate in some people. It can also interact in life-threatening ways with other medications. No adverse events have been reported to date. These products are marketed as dietary supplements. Atomic is packaged in 60- count bottles and Xplode is packaged in 30-count bottles. All lots and codes of Atomic and Xplode are included in this recall and were sold throughout the U.S. through internet sales starting in 2015. The company is asking customers to contact them to arrange for a return or refund. Stop using this product immediately. If you have experienced any … [Read more...]

Sten Z and M1 Alpha Supplements Recalled for Steroids

Andropharm is recalling all lots of Sten Z and M1 Alpha capsules because they contain derivatives of anabolic steroids. This makes these products unapproved drugs, for which safety has not been established. No reports of adverse reactions have been received to date. These product may cause elevated blood pressure, aggressive behavior, male infertility. Those with conditions such as heart disease, liver disease, or prostate issues can be at higher risk. Sten Z and M1 Alpha capsules are marketed as dietary supplements and promoted to increase, sustain, and strengthen muscularity. The two products were packaged as capsules in 60 count bottles with the UPC number 642125502948 (Sten Z) and UPC number 642125502924 (M1 Alpha). These products were sold through retailers nationwide in the … [Read more...]

Ultra-Sten and D-Zine Supplements Recalled for Anabolic Steroids

Hardcore Formulations is recalling all lots and expiration dates of Ultra-Sten and D-Zine capsules because they contain anabolic steroids. The presence of these drugs render them unapproved drugs and subject to recall. No illnesses or adverse effects have been reported to date. Ultra-Zen contains methylstenbolone and D-Zine contains dymethazine. These drugs can cause serious liver injury and also injure the kidneys, cause an increased risk of heart attack and stroke, elevated blood pressure, and other issues. Ultra-Sten and D-Zine capsules are marketed as dietary supplements for body-building and are packaged  in 90-count bottles, with the bar code 7-48252-68763-0 (Ultra-Sten); 7-48252-86193-1 (D-Zine) and sold through retailers nationwide in the USA. This recall applies to all lot … [Read more...]

Tri-Ton Recalled for Unapproved Drugs

Dynamic Technical Formulations is voluntarily recalling all lots of Tri-Ton, a dietary supplement. FDA lab analysis found that it contains mandarine and ostarine, which are selective androgen receptor modulators (SARMs) that are considered unapproved drugs and anabolic steroid-like substances. Use of those substances may cause acute liver injury. Other long term adverse health effects in men, women, and children include male infertility, short stature in children, a higher risk of misusing other drugs and alcohol, and increased risk of heart attack, stroke, and death. The recalled product, Tri-Ton, was sold in 90 count bottles. All lot numbers and expiration dates are recalled. It was sold through retailers nationwide. Shipment was from June 2016 to March 2017. Stop using this … [Read more...]

Caverflo Natural Herbal Coffee Recalled After “An Individual Death”

Caverflo is voluntarily recalling all lots of Caverflo Natural Herbal Coffee after FDA analysis confirmed the presence of Sildenafl and Tadalafil, which are the active ingredients in two prescription drugs for the treatment of erectile dysfunction. Caverflo.com has "received a report of an individual death after use of the coffee." The product may also contain undeclared milk. These undeclared ingredients may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels. And anyone who is allergic to milk or who is lactose intolerant could have a serious reaction if they consume this product. Attorney Brendan Flaherty, who has represented clients injured by dietary supplements, said, "According to the New England Journal of … [Read more...]

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