August 25, 2019

Herbal Doctor Remedies Recalls Products Marketed Without FDA Approval

Herbal Doctor Remedies is voluntarily recalling all drug products within expiration dates to the consumer level. These products were marketed without FDA approval and were manufactured outside controls required by current Good Manufacturing Practices. This could result in risk to consumers, since they are marketed with uses that are not amenable to self-diagnosis. And, lack of controls in the manufacturing of these products do not provide assurance of quality. No reports of adverse reactions have been received to date by the company. These products are intended to be used as Chinese Herbal Medicines, marketed for treatment of diseases in people which the FDA has found makes them unapproved new drugs. These recalled Herbal Doctor products are packaged in white plastic … [Read more...]

Life Rising Supplements Recalled For Possible Lead Contamination

Life Rising Corporation of Willowbrook, Illinois, is recalling  Life Rising Holder-W Holder Warmer capsules, Life Rising NECK-ND Neck Clear capsules, and HoliCare Metabolism Cleansing (MET-CLS) tablets because they may cantina excessive levels of lead. When consumed, lead can cause serious health problems, including damage to the nervous system and internal organs. Symptoms of acute, or short term, lead poisoning include abdominal pain, nausea, muscle weakness, vomiting, diarrhea, weight loss, and bloody urine. The long term consequences of lead poisoning can include learning difficulties, hearing loss, lower IQ, and developmental delay. Children are especially vulnerable to lead poisoning. These recalled dietary supplements were sold mostly in the Chicago area at HoliCare clinics, … [Read more...]

Aphrodisiac Capsules Recalled For Undeclared Sildenafil

SD Import, LLC is recalling all lots of Aphrodisiac Capsules because they contain sildenafil, a prescription drug, that can cause serious health problems. Sildenafil is an active pharmaceutical ingredient that is FDA approved through prescription. Because this ingredient is in this product, it becomes an unapproved drug. Patients who have hypertension, diabetes, heart disease, or high cholesterol are at risk for adverse health effects from this product if they take nitrates. Consumption of sildenafil when a patient is also taking nitrates could cause a serious drop in blood pressure that can be life-threatening. No reports of adverse events have been received to date. These Aphrodisiac Capsules are marketed as a dietary supplement. They are packaged in a cardboard box with 12 plastic … [Read more...]

Kopi Jantan Coffee Recalled For Sildenafil and Tadalafil

Brian Richardson, doing business as "In Tha Pink" is recalling Kopi Jantan Tradisional Natural Herbs Coffee because it contains undeclared Sildenafil and Tadalafil, which are prescription drugs. This makes the coffee an unapproved drug for which safety and efficacy have not been established. These drugs can pose a health threat to consumers. They may interact with nitrates found in some prescription drugs and can lower blood pressure to dangerous, life-threatening levels. Consumers with diabetes, high blood pressure, heart disease, or high cholesterol often take nitrates. No adverse events have been reported to date in connection with this issue. The recalled product is marked as a dietary supplement for sexual enhancement. Kopi Jantan Tradisional Natural Herbs Coffee is sold in … [Read more...]

Indian Herb Dietary Supplement Recalled For Possible Danger

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...]

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