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Acute Non-Viral Hepatitis of Unknown Etiology Potentially Associated with an Alkaline Water Product
Wednesday, March 31, 2021
Five cases of acute non-viral hepatitis of unknown etiology in children were reported to the Southern Nevada Health District (SNHD) between November and December 2020. The Centers for Disease Control and Prevention (CDC) is assisting the SNHD in investigating a potential link between these...
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Lamictal (lamotrigine): Drug Safety Communication - Studies Show Increased Risk of Heart Rhythm Problems in Patients with Heart Disease
Wednesday, March 31, 2021
An FDA review of study findings showed a potential increased risk of heart rhythm problems, called arrhythmias, in patients with heart disease who are taking the seizure and mental health medicine Lamictal (lamotrigine). FDA wants to evaluate whether other medicines in the same drug class have...
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SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests
Wednesday, March 31, 2021
The SARS-CoV-2 virus has mutated over time, resulting in genetic variation in the population of circulating viral strains over the course of the COVID-19 pandemic. Molecular, antigen, and serology tests are affected by viral mutations differently due to the inherent design differences of each test.
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Zydus Pharmaceuticals (USA) Inc. Issues Voluntary Nationwide Recall of Acyclovir Sodium Injection, 50 mg/mL Due to Crystallization
Monday, March 29, 2021
Pennington, NJ, Zydus Pharmaceuticals (USA) Inc. is voluntarily recalling four lots of Acyclovir Sodium Injection, 50 mg/mL, 10 mL and 20 mL vials, to the Hospital/User level after receiving several complaints of crystallization in vials.
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BD Expands Voluntary Recall of ChloraPrep™ 3 mL Applicator Nationwide to Include All U.S. States
Monday, March 29, 2021
BD (Becton, Dickinson and Company), a leading global medical technology company, has revised its press release dated March 19, 2021 relating to an expanded voluntary recall that was initiated on June 23, 2020 for specified catalog numbers of the ChloraPrep™ 3 mL applicator due to possible...
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Personal Protective Equipment EUAs
Thursday, March 25, 2021
Personal Protective Equipment refers to protective clothing, helmets, gloves, face shields, goggles, respirators or other equipment designed to protect the wearer from injury or the spread of infection or illness.
To help address concerns about availability during the COVID-19 pandemic, the FDA has...
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Alembic Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Telmisartan Tablets, USP, 20 mg Due to Label Mix-Up
Thursday, March 25, 2021
Bridgewater, NJ, Alembic Pharmaceuticals, Inc is voluntarily recalling one lot of Telmisartan Tablets, USP, 20 mg, packaged in 30-count bottles, Lot No. 1905005661 to the consumer level. The product is being recalled due to a market complaint received which stated that one bottle labelled as...
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FDA Advises Health Care Professionals not to Use ChloraPrep 3 mL Applicators Manufactured by BD (Becton, Dickinson and Company)
Monday, March 22, 2021
FDA advises health care professionals not to use ChloraPrep 3 mL applicators manufactured by BD (Becton, Dickinson and Company), due to microbial contamination risks. The drug was distributed globally and is labeled with “CareFusion, El Paso, TX.”
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FDA Authorizes Revisions to Fact Sheets to Address SARS-CoV-2 Variants for Monoclonal Antibody Products under Emergency Use Authorization
Friday, March 19, 2021
Today, the U.S. Food and Drug Administration authorized revised fact sheets for health care providers to include additional information on susceptibility of SARS-CoV-2 variants to each of the monoclonal antibody (mAb) therapies that are available through an Emergency Use Authorization (EUA) for the...
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Potential for False Results with Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza Test for use on cobas Liat System-Letter to Clinical Laboratory Staff, Point-of-Care Facility Staff, and Health Care Providers
Monday, March 15, 2021
The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff, point-of-care (POC) facility staff, and health care providers that false positive results can occur with the Roche Molecular Systems, Inc. (Roche) cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the...
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