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News Archives

May 21, 2020: New Hoque and Sons, Inc. Initiates Radhuni Curry Powder Recall For Potential Salmonella Contamination

New Hoque and Sons, Inc. Radhuni Curry Powder Recall News A Radhuni Curry Powder Recall has been announced by distributor, New Hoque and Sons, Inc. of Maspeth, NY, because the product may be contaminated with the foodborne pathogen, Salmonella.  The curry product affected by the recall is packaged in 400g plastic bottles.   Radhuni Curry Powder Recall Product Information Curry Powder affected by the Radhuni Curry Powder Recall was distributed in New York City, NY, including grocery stores located in the Bronx, Jackson Heights, and Jamaica. The product was distributed to grocery stores between 4/17/2020 and 4/21/2020. The company reported that the recalled curry powder was physically removed from the stores on 5/14/2020. The recalled product is labeled “Radhuni Curry Powder”. The product is contained in 400g clear, plastic bottles, with an expiration date of 01/02/2022, which can be found Read More

May 20, 2020: Biota Biosciences Issues Recall for Several CBD Injectable Products Marketed Without FDA Approval

Biota Biosciences CBD Recall News – Biota Biosciences has issued a recall for certain CBD injectable products marketed without approval by the U.S. Food and Drug Administration (FDA). Biota Biosciences CBD Recall Information On May 20, 2020, Biota Biosciences recalled the following Cannabidiol (CBD) products: CBD Complex, Curcumin Complex, and CBD + Curcumin Injectables. These injectable CBD products were marketed without FDA approval. The products were also misbranded due to labels failing to state appropriate directions for use. Per the FDA and Biota Biosciences notification, Cannabidiol (CBD) Complex was marketed to suppress pain and aid in the detoxification processes as a promising therapeutic for a wide array of disorders such as epilepsy, including many challenging neuropathy conditions. Curcumin Complex was marketed as a potent anti-inflammatory and antioxidant that may also help improve symptoms of depression and arthritis. Cannabidiol + Curcumin Read More

Credit: FDA

May 15, 2020: Summitt Labs Issues Nationwide Recall of KORE ORGANIC Watermelon CBD Oil Due to High Lead Results

KORE ORGANIC Watermelon CBD Oil Recall News – Summit Labs has issued a recall for its KORE ORGANIC Watermelon CBD Oil Tincture due to test results showing high lead levels. KORE ORGANIC Watermelon CBD Oil Recall Informaton On May 12, 2020, Summit Labs issued a recall for its KORE ORGANIC Watermelon CBD Oil Tincture due to high lead levels. The products affected include the following information: Batch#730 Lot#K018, 30 ml bottle, 15mg 450x. The Florida Department of Agriculture and Consumer Services tested a random sample from Summit Labs’ KORE ORGANIC Watermelon CBD Oil and found lead levels at 4.7 parts per million (ppm). Summit Labs launched an investigation into the elevated lead levels in its KORE ORGANIC Watermelon CBD Oil by sending a sample of the affected batch to an ISO/IEC accredited lab. The lab yielded lead results at 0.5 Read More

May 15, 2020: FDA Issues Public Alert Regarding Accuracy Concerns With Abbott ID NOW Point-of-Care Test for Diagnosing COVID-19

On May 15, 2020, the U.S. Food and Drug Administration (FDA) issued an alert for the public advising that early data for the Abbott ID NOW point-of-care test, used to diagnose COVID-19 (coronavirus), suggest possible inaccurate results which elicit false negatives. Abbott ID NOW COVID-19 Test Alert Information The FDA is issuing this information as a gesture of transparency regarding testing. They are working closely with Abbott to review the available data and information. Abbott is collaborating with the FDA to draft a customer notification letter alerting consumers that any negative test results not consistent with a patient’s clinical signs and symptoms should be followed up and confirmed with another test. Per Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health: We are still evaluating Read More

Credit: FDA

May 14, 2020: Ramar Foods Recalls Peekaboo Mint Chocolate Chip With Hidden Spinach Ice Cream due to Listeria

Peekaboo Ice Cream Recall News – Ramar Foods, of Pittsburg, CA has issued a recall for its 14 ounce containers of Peekaboo branded Mint Chocolate Chip with Hidden Spinach Ice Cream product due to a possible Listeria monocytogenes (Listeria) contamination. Peekaboo Ice Cream Recall Information On May 14, 2020, Ramar Foods recalled its Peekaboo branded Mint Chocolate Chip with Hidden Spinach Ice Cream (14 ounce containers) due to a potential Listeria exposure. This Peekaboo ice cream product was available for purchase at Target stores in Florida, Georgia, South Carolina, and North Carolina.  The affected product comes in a 14 ounce container with UPC# 8685400001 and a “Best Before” date of 10/08/2021 printed on the bottom. Ramar Foods found the presence of Listeria during routine internal testing.  They are working with the U.S. Food and Drug Administration (FDA) to investigate. Consumers who purchased Read More

May 14, 2020: Federal Judge Issues Injunction Against Xephyr LLC d/b/a N-Ergetics for continued sale of unapproved COVID-19 Products

N-Ergetics Federal Injunction News – A Federal Judge entered a temporary restraining order against Xephyr, LLC doing business as N-Ergetics, and three individuals associated with the business, requiring them to immediately stop sale and distribution of colloidal silver products. N-Ergetics Federal Injunction Information On May 14, 2020, a Federal Court issued an injunction against N-Ergetics and associated individuals for the immediate stoppage of distribution and sale of colloidal silver products marketed for the treatment or cure of COVID-19 (coronavirus) and other diseases. N-Ergetics defied the U.S. Food and Drug Administration (FDA) and Federal Trade Commission’s (FTC) March 6, 2020 warning letter regarding their colloidal silver products. The Court found that the United States demonstrated that N-Ergetics and those associated named in the injunction are in violation of the Federal Food, Drug, and Cosmetic Act (FD&C) by unlawfully selling and distributing Read More

May 11, 2020: UNFI Voluntarily Recalls Wild Harvest® Organic Basil Due to Possible Cyclospora cayetanensis Contamination

Wild Harvest® Organic Basil Recall News – United Natural Food, Inc. (UNFI) has recalled its Wild Harvest® Organic Basil distributed out of UNFI’s Hopkins, MN distribution center due to the potential to be contaminated with Cyclospora cayetanensis (Cyclospora). Wild Harvest® Organic Basil Recall Information On May 11, 2020, UNFI issued a recall for its Wild Harvest® Organic Basil due to possible exposure to Cyclospora.  The concern was revealed through routine sampling. The affected product was sold to and through select retailers in Minnesota between 4/18/20 – 5/8/20.  This recall includes Wild Harvest® Organic Fresh Basil products sold in 0.25oz, 0.75oz, 2oz, and 4oz plastic clam shell containers (UPCs: 0071153550450, 0071153550322, 0071153550762, 0071153550323).  The impacted Wild Harvest® Organic Basil products can be identified by a white sticker with black ink on the back of the container stating: “Product of Colombia” and “112″. Read More

May 7, 2020: FDA Continues its Fight Against Fake COVID-19 Medical Products

On May 7, 2020, the U.S. Food and Drug Administration (FDA) issued an update as to its continued efforts to combat fraudulent information and products marketed by individuals and companies to cure or treat COVID-19 (coronavirus). To date, the FDA has issued 42 warning letters to companies claiming their products can aid against coronavirus, including Genesis II Church and its “Miracle Mineral Solution“. On April 17, 2020, a Federal Judge entered a temporary injunction against Genesis II Church for not complying with the FDA’s warning letter. Information on the FDA’s Operation The FDA has dubbed their work towards identifying fake medical products geared towards COVID-19 as “Operation Quack Hack”. Over the past few weeks, the FDA has uncovered hundreds of fraudulent products including drugs, testing kits, and personal protective equipment (PPE) sold online with accompanying unproven claims. Online marketplaces, domain Read More

May 7, 2020: FDA Advises Certain Filtering Facepiece Respirators from China May Not Provide Appropriate Respiratory Protection

Respirators from China News – The U.S. Food and Drug Administration (FDA) has issued a letter to the following regarding concerns with certain filtering facepiece respirators (respirators) from China: Chinese companies producing the at issue respirators, U.S. Health Care Personnel, Hospital Purchasing Departments/Distributors, and other applicable stakeholders/consumers. Respirators from China Information On May 7, 2020, the FDA issued a letter regarding concerns over certain respirators from China. The outlined respirators may not provide consistent and adequate respiratory protection to health care personnel exposed to COVID-19 (coronavirus) based on additional filtration performance testing conducted by the National Institute for Occupational Safety and Health (NIOSH) and National Personal Protective Technology Laboratory (NPPTL) of the Centers for Disease Control and Prevention (CDC). Pursuant to the testing, the FDA has revised and reissued its April 3, 2020 Emergency Use Order (EUA). Per the FDA, Read More

May 1, 2020: FDA Issues Emergency Use Authorization for Possible COVID-19 Treatment

On May 1, 2020, The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the antiviral drug remdesivir to be used as a potential treatment for coronavirus (COVID-19). This allows for hospitals and healthcare facilities to use remdesivir on patients, both children and adults, with suspected or confirmed coronavirus and severe disease. Severe disease is defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator. Remdesivir Information The FDA advises that while there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19, a clinical trial has shown that it seems to shorten recovery time in some patients. Based on evaluation of the emergency use authorization criteria and the scientific evidence available, the FDA Read More

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