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News Archives

April 17, 2020: Federal Judge Enters Temporary Injunction Against Genesis II Church For Continuing to Market “Miracle Mineral Solution”

Genesis II Church Injunction News – The U.S. Food and Drug Administration (FDA) announced that a Federal Judge issued a temporary injunction against Genesis II Church for failure to comply with the FDA’s April 8, 2020 warning letter ordering Genesis II Church to stop claiming its “Miracle Mineral Solution” (“MMS”) could treat or prevent COVID-19 (coronavirus). Genesis II Church Injunction Information On April 17, 2020, a Federal Judge issued a temporary injunction against Genesis II Church for failing to comply with the FDA’s warning letter. Genesis II Church has been marketing its MMS as a prevention and treatment towards coronavirus. The Court found that the United States demonstrated that Genesis II Church and the affiliated individuals named in the injunction are violating the Federal Food, Drug, and Cosmetic Act (FD&C) by unlawfully distributing MMS. The FDA has cautioned that MMS is Read More

April 8, 2020: FDA Issues Warning Letter to Genesis II Church for Selling Fraudulent Products related to Coronavirus (COVID-19)

Genesis II Church Warning Letter News – The U.S. Food and Drug Administration (FDA) has issued a warning letter to Genesis II Church of Health and Healing regarding its marketing of fraudulent and dangerous chlorine dioxide products known as “Miracle Mineral Solution” as a means of prevention and treatment of the “Novel Coronavirus Disease 2019” (COVID-19). Genesis II Church Warning Letter Information On April 8, 2020, the FDA issued a warning letter to Genesis II Church for its marketing of “Miracle Mineral Solution” as a treatment and cure for COVID-19. The FDA is not aware of any scientific evidence supporting the safety or effectiveness of chlorine dioxide products sold online as medical treatments and, further, they pose significant risks to patient health. Per the FDA: “Despite previous warnings, the FDA is concerned that we are still seeing chlorine dioxide products Read More

April 3, 2020: FDA Issues Update on COVID-19 (Coronavirus) Response

FDA COVID-19 Update News – On April 3, 2020, the U.S. Food and Drug Administration (FDA) issued an announcement with their continuing COVID-19 response. FDA COVID-19 Update Information The FDA has announced the following updates: They are working in collaboration with government, industry, and academic partners to develop and implement a protocol to provide convalescent plasma to patients in need throughout the U.S. Convalescent plasma, or plasma from people who have had the virus, has the potential to lessen the severity or shorten the length of illness from COVID-19. An FAQ as to whether respirators approved under standards used in other countries, such as KN95s, can be used in the US during the COVID-19 pandemic has been posted. A new Emergency Use Authorization (EUA) for non-NIOSH-approved respirators made in China has been issued allowing use of respirators approved in other countries, under Read More

April 1, 2020: FDA Requests Removal of All Ranitidine Products (Zantac) from Market

FDA Ranitidine (Zantac) Removal News – The U.S. Food and Drug Administration (FDA) has requested that all products containing Ranitidine (commonly known by the brand name: Zantac) be removed from the market due to an impurity having potential to cause cancer. Ranitidine (Zantac) Removal Information On April 1, 2020, the FDA issued a statement requesting that manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is due to the fact that a contaminant known as N-Nitrosodimethylamine (NDMA) was found in Zantac and in other ranitidine medications, per an ongoing investigation. As a result of the FDA’s immediate market withdrawal request, Zantac and other ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S. The FDA is sending letters to all manufacturers of Zantac and ranitidine products requesting they Read More

March 6, 2020: FDA and FTC Issue Warning Letter to Xephyr, LLC d/b/a N-Ergetics for Unapproved and Misbranded Products Related to COVID-19

N-Ergetics Warning Letter News – The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have issued a joint warning letter to Xephyr, LLC d/b/a N-Ergetics (N-Ergetics)for listing and promoting colloidal silver products on its website for sale in the United States, intended to mitigate, prevent, treat, cure or diagnose COVID-19 (coronavirus) in people. N-Ergetics Warning Letter Information On March 6, 2020, the FDA and FTC jointly issued a warning letter to N-Ergetics for selling misbranded and unapproved products on its website intended to treat or prevent COVID-19. Per the FDA and FTC’s warning letter: FDA has determined that these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). Furthermore, these products are misbranded drugs under section 502 of the FD&C Act, Read More

FEBRUARY 25, 2019: Xeljanz Side Effects – Increased Risk Of Pulmonary Embolism And Death With Higher Dose Of Tofacitinib (Xeljanz And Xeljanz XR) In Rheumatoid Arthritis Patients Reported

Increased Death and PE Risk Observed in Xeljanz (tofacitinib) Post Marketing Study Xeljanz Side Effects – The US Food and Drug Administration (FDA) announced on February 25, 2019, that data from an ongoing post marketing study has demonstrated an increased risk of pulmonary embolism (PE) and death in rheumatoid arthritis (RA) patients treated with a 10 mg twice daily dose of tofacitinib (marketed as Xeljanz, Xeljanz XR). The FDA has not approved the 10 mg twice daily dose of tofacitinib for rheumatoid arthritis; however, this dose is approved in the treatment of ulcerative colitis. Tofacitinib (Xeljanz, Xeljanz XR) Post Marketing Study Requirement At the time of marketing approval, the FDA required Xeljanz manufacturer, Pfizer, to conduct a post marketing study in patients with RA to evaluate the risk of cardiovascular events, cancer, and opportunistic infections. The study followed patients taking Read More

August 31, 2018: FDA Announces Recall Montelukast Tablet Recall For Incorrect Drug In Bottles

FDA Montelukast Tablet Recall Announcement The U.S. Food and Drug Administration(FDA) is warning consumers and health care professionals of a recall for one lot of Montelukast Sodium Tablets – lot number MON17384, expiration 12/31/2019 – by Camber Pharmaceuticals, Inc., of Piscataway, N.J. According to the FDA announcement, the Montelukast Tablet Recall was initiated because sealed bottles labeled as montelukast sodium tablets, 10 milligram, 30-count bottle from Camber were found to instead contain 90 tablets of Losartan Potassium Tablets, 50 mg. FDA Statement Regarding The Montelukast Tablet Recall This tablet mix-up may pose a safety risk as taking losartan tablets when not prescribed has the potential to cause renal dysfunction, elevated potassium levels and low blood pressure. This risk is especially high for pregnant women taking the allergy and asthma medication montelukast because losartan, which is indicated to treat high blood Read More

August 27, 2018: Accord Healthcare Recalls Hydrochlorothiazide Tablets – One Lot

Accord Healthcare Recalls Hydrochlorothiazide Tablets Accord Healthcare Inc., has recalled one lot (Lot PW05264 – 46632 Bottles, NDC 16729-182-01) of Hydrochlorothiazide Tablets USP, 12.5 mg, due to a potential product labeling error. Specifically, a 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg was found to contain 100 Spironolactone Tablets USP 25 mg, according to the company’s recall announcement. Accord Healthcare became aware of the mix-up through a product complaint reported from a pharmacy. About Spironolactone and Hydrochlorothiazide Accord Healthcare provided the following medication information to consumers: “Spironolactone tablets are indicated in the management of primary hyperaldosteronism, edematous conditions for patients with congestive heart failure, cirrhosis of the liver accompanied by edema and/or ascites, nephrotic syndrome, essential hypertension, hypokalemia, severe heart failure. Use of spironolactone tablets instead of hydrochlorothiazide tablets, poses the risk of contracting hyperkalemia (increase potassium levels) in Read More

August 3, 2018: FDA Warns For Increased Risk of Cancer Relapse With Long-term Use of Azithromycin After Stem Cell Transplant

Azithromycin Safety Announcement – In a Safety Announcement dated August 3, 2018, The U.S. Food and Drug Administration (FDA) warned that the antibiotic azithromycin (Zithromax, Zmax) should not be given long-term to prevent a certain inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. The announcement was made after results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes, including death, in these patients. The FDA is reviewing additional clinical data regarding this matter, and will communicate their findings and recommendations when the review is complete. Azithromycin Manufacturer Issues “Dear Healthcare Provider Letter” The FDA Safety Announcement stated: “The serious lung condition for which long-term azithromycin was being studied called bronchiolitis obliterans syndrome is caused by inflammation and scarring in Read More

July 13, 2018: FDA Announces Valsartan Recall Due To Detection Of Impurity

Detection Of Impurity Prompts Valsartan Recall On July 13, 2018, the FDA alerted health care professionals and patients of a recall for multiple drug products containing the active pharmaceutical ingredient, valsartan, because the products contained an impurity known as N-nitrosodimethylamine (NDMA). Not all products containing valsartan are subject to the valsartan recall. The FDA cautioned that “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.” Valsartan Recall Information for Patients and Health Care Professionals Valsartan is prescribed to treat high blood pressure and heart failure. The FDA has provided health care professional and the public with the following safety information. Patients should neither start nor stop taking Read More

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