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News Archives

July 8, 2020: Postmarket Surveillance Results for Essure Birth Control Issued by FDA

Essure Postmarket Surveillance Results News – The U.S. Food and Drug Administration (FDA) has posted interim results for the postmarket surveillance study of Essure, a permanent implanted birth control device for women. Sales of Essure in the U.S. stopped in December 2018. Implantation of the Essure birth control device is no longer available as of December 2019. Essure Postmarket Surveillance Results Information On July 8, 2020, the FDA issued its postmarket surveillance results for Essure. The FDA has continued to recommend that women who have been using Essure successfully can and should continue to do so. But, women who believe the device may be related to certain symptoms they have, such as persistent pain, should speak with their doctor about appropriate steps. Patients should discuss the risks and benefits of any procedure with their doctor before deciding on the best Read More

June 19, 2020: FDA Warns Consumers not to use hand sanitizer products made by Eskbiochem

FDA’s Eskbiochem Warning News – The U.S. Food and Drug Administration (FDA) has advised consumers not to use any hand sanitizer manufactured by Eskbiochem SA de CV in Mexico, due to the potential presence of methanol (wood alcohol), a substance that can be toxic when absorbed through the skin or ingested. Eskbiochem Warning Information On June 19, 2020, the FDA stated that the following products manufactured by Eskbiochem should not be used: All-Clean Hand Sanitizer (NDC: 74589-002-01) Esk Biochem Hand Sanitizer (NDC: 74589-007-01) CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol (NDC: 74589-008-04) Lavar 70 Gel Hand Sanitizer (NDC: 74589-006-01) The Good Gel Antibacterial Gel Hand Sanitizer (NDC: 74589-010-10) CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol (NDC: 74589-005-03) CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol (NDC: 74589-009-01) CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol (NDC: 74589-003-01) Saniderm Advanced Hand Sanitizer (NDC: Read More

June 19, 2020: FDA Cautions Certain COVID-19 Serology/Antibody Tests Should Not Be Used

COVID-19 Antibody Tests News – The U.S. Food and Drug Administration (FDA) has recommended that clinical laboratories and health care providers stop using COVID-19 antibody tests listed on the FDA’s “removed” test list. On May 15, 2020, the FDA also issued a public alert regarding the accuracy of the Abbott ID NOW point-of-care test for diagnosing COVID-19. COVID-19 Antibody Tests Information On June 19, 2020, the FDA issued a letter to clinical labs and health care providers advising that certain COVID-19 antibody tests should not be used. The FDA’s “removed” test list should be used by providers as a guideline for what tests to avoid. This list includes tests where significant clinical performance problems were identified that cannot be, or have not been, addressed by the commercial manufacturer in a timely manner and tests for which an Emergency Use Authorization 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

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 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

April 24, 2020: FDA Cautions Against Use of Chloroquine or Hydroxychloroquine for COVID-19 Treatment outside of Hospital Setting or Clinical Trial

On April 24, 2020, the U.S. Food and Drug Administration (FDA) issued an announcement cautioning use of hydroxychlroquine or chloroquine outside of a hospital setting or clinical trial due to potential hazardous and fatal outcomes. The FDA had issued an Emergency Use Authorization (EUA) for temporary use of hydroxychlorquine and chloroquine in COVID-19 patients only when clinical trials were not available. These medicines have numerous side effects, including but not limited to serious heart rhythm problems that can be life-threatening. Issues With Unsupervised Use of Chloroquine and Hydroxychlroquine Officials at the FDA have reviewed data from the FDA Adverse Event Reporting System database, published medical literature, and the American Association of Poison Control Centers National Poison Data System concerning serious heart-related adverse events and death in patients with COVID-19 receiving hydroxychloroquine and chloroquine, either alone or combined with azithromycin or other Read More

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