Regenecare HA Hydrogel Recall News – MPM Medical has issued a recall for one lot of Regenecare HA Hydrogel. Following customer complaints of visible contamination, the Regenecare product tested positive for Burkholderia cepacia (B. cepacia). Regenecare HA Hydrogel Recall Information On December 2, 2020, MPM Medical, of Mesquite, TX, issued a recall for one lot of its Regenecare HA Hydrogel product due to a B. cepacia contamination. The affected product was packaged in 3 oz. plastic tubes and distributed in boxes of 12. The recalled Regenecare HA Hydrogel can be identified by the following: NDC #66977-107-03; Lot #41262; Date: 2021-01 This product was distributed nationwide to wholesalers and healthcare facilities. Patients and healthcare facilities with this affected lot of Regenecare HA Hydrogel should stop use immediately. Consumers should contact their healthcare provider or physician if they have experienced any problems. Read More
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June 15, 2020: COVID-19 Update: FDA Revokes Emergency Use Authorization for chloroquine phosphate and hydroxychloroquine sulfate
Chloroquine and Hydroxychloroquine News – The U.S. Food and Drug Administration (FDA) has revoked its Emergency Use Authorization (EUA) regarding chlroquine and hydroxychloroquine as it has been found that these drugs do not effectively treat COVID-19. Chloroquine and Hydroxychloroquine Information On June 15, 2020, the FDA issued a letter revoking its EUA for hydroxychloroquine and chloroquine as to treatment for COVID-19. The FDA has based this revocation on facts that have become available throughout this pandemic. Clinical trial results have shown that hydroxychloroquine and chloroquine may not be effective in treating COVID-19 cases. In fact, it is noted that the possible benefits do not outweigh the potential and known risks. This decision was issued after analysis of new and previously available information. The FDA also advised in a different notice today that remdesivir should not be co-administered with chloroquine or Read More
June 15, 2020: FDA Warns of Potential Drug Interaction Between Remdesivir and Hydroxychloroquine
Remdesivir Drug Interaction News – The U.S. Food and Drug Administration (FDA) has warned of a newly discovered potential drug interaction between remdesivir and chloroquine phosphate or hydroxychloroquine sulfate, which can reduce the effectiveness of remdesivir. Remdesivir Drug Interaction Information On June 15, 2020, the FDA announced that the co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as when remdesivir is mixed with the latter two drugs, a reduction in the effectiveness of remdesivir’s treatment may occur. Per Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation and Research: Over the course of this unprecedented pandemic, the FDA has issued emergency use authorizations for a variety of medical products after evaluating the available scientific evidence and carefully balancing any known or potential risks against the benefits of making these products available during the 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
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 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 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
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
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
