Felt, OK, McDaniel Life-Line LLC is recalling all lots of Indian Herb b because it is marketed without an approved NDA/ANDA (new drug application/abbreviated new drug application). The recall statement says, "The therapeutic claims made in the labeling for this product establish that it is a drug because it is an article (other than food) intended to affect the structure or any function of the body. Additionally, the product contains ingredients that the Agency has determined to be caustic in nature that can cause serious injury. "Use of the product could result in temporary or permanent damage or loss of body function or structure. To date, McDaniel Life-Line LLC has received a report of one adverse injury." An NDA helps the FDA decide "whether the drug is safe and effective in … [Read more...]
Rhino 5K Capsules Recalled for Unapproved Drugs
Happy Together, a company in Boynton Beach, Florida, is recalling all lots of Rhino 5K capsules because they are tainted with sildenafil and Tadalafil. Sildenafil and Tadalafil are FDA approved drugs that are available only through prescription. Those drugs render the product as a whole an unapproved drug for which efficacy and safety has not been established, therefore subject to recall. No adverse reactions have been reported to date in connection with this recall. Men with diabetes, high blood pressure, heart disease, or high cholesterol may be taking prescription meds that could interact with these products and cause dangerously low blood pressure that could be life-threatening. The company can't identify customers who bought this product, so they are making a public announcement … [Read more...]
Zero Xtreme Dietary Supplement Recalled for Sibrutramine
Fat Burners Zone is recalling one lot of Zero Xtreme capsules, a dietary supplement intended for weight loss, because it is contaminated with sibutramine, according to FDA analysis. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market for safety concerns. That means Zero Xtreme is an unapproved drug. Sibutramine is the active ingredient in Meridia, a drug that was marketed in the 1990s for prescription treatment of obesity. It was withdrawing 2010 after clinical dates indicated "Sibutramine poses an increased risk of heart attack and stroke." The product can substantially increase blood pressure and pulse rate, and can present a health risk for anyone with a history of coronary artery daisies, congestive heart failure, arrhythmias, and stroke. No adverse events … [Read more...]
King Bio It’s Kids and Infant Products Recalled for Possible Microbial Contamination
King Bio is voluntarily recalling It's Kids and Infant products for possible microbial contamination. A small percentage of products that were made between 08/01/2017 and 04/2018 tested positive for bacteria. The recall notice did not state which bacteria were found. These drug products could cause infections that may require a doctor's care. Some children could develop a serious illness, according to the recall notice. No illnesses have been reported to date in connection with this recall. You can see the long list of recalled products, along with package sizes, intended use, UPC numbers, and lot numbers at the FDA web site. Some of the recalled products include DK Attention & Learning, Chicken Pox Symptom Relief, Children's Appetite & Weight, Children's Feet Reducer, DK … [Read more...]
Blissful Remedies Mitragyna Speciosa Recalled for High Microbial Counts
World Organix LLC is recalling Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa capsules, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend for high microbial counts. The products were tested by the FDA. This recall is also an update about the products Blissful Remedies Gold Series Ultra Enhanced Indo and Blissful Remedies Kratom + CBD, CBD infused Maeng Da, Red Maeng Da 100% Mitragyna Speciosa, that were recalled for possible Salmonella contamination. No reports of any illness have been received due to the high microbial counts or Salmonella contamination. These are unapproved products, according to the FDA recall notice. The Maeng Da products contain M. speciose, which has psychoactive properties. The recall … [Read more...]
Two Recalls: One for Chicken Produced Without Inspection; Another for Allergens in Supplements
Two recalls have been issued by the USDA and FDA for two different products. Halal chicken has been recalled for lack of inspection, and dietary supplements are recalled for undeclared allergens. No illnesses or allergic reactions have been reported to date in either recall. The first recall is for Afandina Halal's raw poultry products that were produced without the benefit of several inspection. These raw chicken items were produced and packaged from May 14 through June 22, 2018. They include 40-pound bulk boxes containing “Afandina, Halal Wholesale Chicken, Boneless Leg Meat,” 40-pound bulk boxes with “Afandina, Halal Chicken, Whole Chicken Legs,” and 40-pound bulk boxes with “Afandina, Halal Chicken, Chicken Cutlets.” These products have the establishment number "P-51183" inside the … [Read more...]
Two Manufacturers Recall Kratom Supplements for Possible Salmonella
Two manufacturers are recalling kratom-containing dietary supplements for possible Salmonella contamination. Illness have been reported tied to these recalled products. Badger Botanicals of Utah is recalling Green Suma, Red Suma, Green Hulu 2, and Red Hulu 2 kratom dietary supplements that were sold directly to consumers through the company website from January 1, 2018 to April 12, 2018 because it has the potential to be contaminated with Salmonella. One potential illness has been reported in connection with this issue. There is a multistate Salmonella outbreak linked to some kratom containing products in the U.S. right now. At least 132 people are sick in this outbreak as of April 5, 2018, according to the FDA. We don't know whether or not the illness reported in this recall is … [Read more...]
Labrada Nutrition Recalls LeanPro8 Protein Powder For Undeclared Egg
Labrada Nutrition of Houston, Texas is recalling some lots of LeanPro8 Protein Powder for undeclared egg, which is one of the eight major food allergens. People who are allergic to egg could have a serious reaction if they consume this product. No illnesses or reactions have been reported to date in connection with this problem. LeanPro8 was sold nationwide through retail sales and through mail orders. It comes in 2.2 pound and 5 pound tubs. The lot numbers are marked on the bottom of the product. The recalled products include Lean Pro 8 Vanilla 2,268g (5 pound) Tub with UPC number 710779112834 and lot number 073437. The following products also have that UPC number: Lean Pro 8 Vanilla 2,268 g (5 pound) tub with lot number 073447; Lean Pro 8 Vanilla 2,268 g (5 pound) tub with lot … [Read more...]
More Kratom Products Recalled for Possible Salmonella Contamination
Several more kratom products have been recalled for possible Salmonella contamination. These four recalls have been listed by the FDA. The first recall is for products made by Viable Solutions for Herbal Salvation Dietary Supplements. You can see the list of products, along with the product name and net weight at the FDA site. These are the lot numbers of the recalled products; RVS1380182301, RVB1380182201, GVH1380171512, and MD13120181601. They were sold directly to consumers nationwide in January and February 2018 through company websites. The company was notified by the Michigan Department of Health that certain lots tested positive for Salmonella. The second recall is for products from Triangle Pharmanaturals of Las Vegas, Nevada. All of its kratom products the company … [Read more...]
Kratom Maeng Da Red Powder and Capsules Recalled for Possible Salmonella
Club 13 of Augustine, Florida, has recalled Maeng Da Red kratom powder that was sold in several forms because it may be contaminated with Salmonella bacteria. No illnesses have been reported to date in connection with the products that have the lot numbers listed below, but there is a multistate Salmonella outbreak linked to kratom containing products in the U.S. at this time. These pouches and bottles of powder and capsules were distributed nationwide in retail stores and through mail order. The "Maeng Da Red" powder products are packaged in 15-gram, 30-gram, 90-gram, 150-gram, and 454-gram packages marked with lot # MRMD012618 on the back of the pouch. The "Maeng Da Red" capsule products come in 5-count, 25-count, 50-count, 100-count, 120-count capsule bottles. The bottles are … [Read more...]
