The FDA has said it has recalled and destroyed products made with kratom, and warns consumers that the substance can be hazardous. The supplements it has collected and destroyed were distributed nationwide under the brand names Botany Bay, Enhance Your Life, and Divinity by Divinity Products Distribution of Grain Valley, Missouri. The company has agreed to stop selling all products containing kratom. The FDA is also encouraging all companies that sell products containing kratom to take steps to remove their products from the market and submit evidence to the FDA to evaluate them according to the regulatory pathway. Government officials are concerned about this product since the FDA has stated that 36 deaths are related to the use of the product. In addition, kratom products … [Read more...]
FDA Recalls and Destroys Kratom Products; Kratom is Associated with a Multistate Salmonella Outbreak
Bulletproof 360 Recalls Collagen Protein Dietary Supplement for Undeclared Milk
Bulletproof 360 is voluntarily recalling one lot of Bulletproof Collagen Protein dietary supplement for undeclared milk, one of the major food allergens. Anyone who is allergic to milk could have a serious reaction if they eat this product. Milk protein was inadvertently added to the product, so those who are lactose intolerant should not be affected. No reactions or other adverse effects have been reported to date in connection with this issue. The recalled product is Bulletproof Collagen Protein dietary supplement, which is packaged in a 16 ounce composite-film bag. The UPC number of the recalled product is 8 15709 02115 3. The lot number is 1017088 and is found on the back panel of the bag. The expiration date is EXP03/19, which means it expires in March of 2019. All other lots of … [Read more...]
Sienna Laxative and Flawless Beauty Recalled for Mislabeling and Unapproved New Drug
Two products regulated by the FDA have been recalled; one, Sienna Laxative, for mislabeling, and the other, Flawless Beauty products, because it contains an unapproved new drug. No illnesses or adverse reactions have been reported. The first recall is for Flawless Beauty products. In accordance with a Consent Decree of Permanent Injunction, the company is voluntarily recalling all lots of 19 different products that were sold individually or as part of multi-unit kits because they are unapproved new drugs. These products were sold over the internet to U.S. and foreign customers. All glutathione products were sold in multi-vial whitening kits. The FDA believes that these drugs present serious public health risks. You can see the long list of recalled products at the FDA web site. … [Read more...]
Two Dietary Supplements Recalled for Possible Salmonella Contamination
Two dietary supplements: Break Ventures "Zero For Him" and "Arthri-D" are being recalled for possible Salmonella contamination. No illnesses have been reported to date in connection with this issue. Zero for Him is a supplement that is distributed nationwide through Amazon. The product has 150 capsules in a 400 cc Light Amber PETE bottle. The lot number is 1710-638 on the bottom. The expiration date of November 2020 is stamped on the side of the container. Routine testing by the company discovered the potential for contamination found Salmonella bacteria in one bottle. the product has been tested and re-tested and no more bacteria were found, but the supplement is being recalled out of an abundance of caution. Distribution of the product is suspended while the FDA and the company … [Read more...]
Marmex Corporation Recalls Blue Pearl Dietary Supplement for Undeclared Sildenafil
Marmex Group is voluntarily recalling all lots of Blue Pearl All Natural Male Enhancement Supplement because the product contains sildenafil, which makes it an unapproved drug. Products with undeclared sildenafil may pose a threat to consumers because the active ingredient can interact with nitrates in some prescription drugs and lower blood pressure to dangerous levels. No adverse effects have been reported to date in connection with this issue. Consumers with high blood pressure, diabetes, high cholesterol, or heart diseases often take nitrates and may be the most likely to be affected by this undeclared drug. The safety and efficacy of this product has not been established. The recalled products is Blue Pearl All Natural Male Enhancement Supplement capsules in 500 mg packages. … [Read more...]
Nutra Labs Recalls Dietary Supplements for Undeclared Drugs
Nutra Labs is voluntarily recalling two dietary supplements because they contain sildenafil, the active pharmaceutical ingredient in an FDA approved product used for erectile dysfunction. This makes these supplements unapproved new drugs. No illnesses or reactions have been reported to date in connection with this problem. The recalled products are Bull in 1800 mg capsules with a production date of 05/08/2016 and Chao Jimengnan 150 mg tablets with lot #20151018. FDA analysis found that Bull had contamination of 0.026mg/capsule, and 70.46 mg/table for Chao Jimengnan. The expiration dates are 05/07/2019 for Bull and 10/2017 for Chao Jimengnan. This drug can be dangerous because its active ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin. … [Read more...]
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...]
