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FDA Authorizes Revisions to Fact Sheets to Address SARS-CoV-2 Variants for Monoclonal Antibody Products Under Emergency Use Authorization

The U.S. Food and Drug Administration (FDA) authorized revised fact sheets for healthcare 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 treatment of COVID-19. FDA is providing this information to equip healthcare providers with the

By |2021-03-24T20:24:55+00:00March 24th, 2021|alerts|Comments Off on FDA Authorizes Revisions to Fact Sheets to Address SARS-CoV-2 Variants for Monoclonal Antibody Products Under Emergency Use Authorization

FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine

The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and

By |2021-03-02T15:55:54+00:00March 2nd, 2021|alerts|Comments Off on FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine

Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19

The U.S. Food and Drug Administration (FDA) is alerting patients and healthcare providers of the risk of false results, particularly false negative results, with the Curative SARS-Cov-2 test. Risks to a patient of a false negative result include: delayed or lack of supportive treatment; lack of monitoring of infected individuals and their household or other

By |2021-01-07T17:16:46+00:00January 7th, 2021|alerts|Comments Off on Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19

Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg

Nostrum Laboratories, Inc. is voluntarily recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) at the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day as published in the

By |2021-01-07T17:14:14+00:00January 7th, 2021|alerts|Comments Off on Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg

FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines

Two different mRNA vaccines have now shown remarkable effectiveness of about 95 percent in preventing COVID-19 disease in adults. As the first round of vaccine recipients become eligible to receive their second dose, we want to remind the public about the importance of receiving COVID-19 vaccines according to how they’ve been authorized by the FDA

By |2021-01-07T17:11:56+00:00January 7th, 2021|alerts|Comments Off on FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines

Increase in Fatal Drug Overdoses Across the United States Driven by Synthetic Opioids Before and During the COVID-19 Pandemic

The purpose of this Health Alert Network (HAN) Advisory is to alert public health departments, healthcare professionals, first responders, harm reduction organizations, laboratories, and medical examiners and coroners to— substantial increases in drug overdose deaths across the United States, primarily driven by rapid increases in overdose deaths involving synthetic opioids excluding methadone (hereafter referred to

By |2020-12-18T17:15:46+00:00December 18th, 2020|alerts|Comments Off on Increase in Fatal Drug Overdoses Across the United States Driven by Synthetic Opioids Before and During the COVID-19 Pandemic

Baxter Healthcare Recalls Baxter SIGMA Spectrum Infusion Pumps with Master Drug Library (Versions 6 and 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software Due to Unplanned Shutdown Issues

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Products Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) Product Code: 35700ABB and 35700BAX Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)

By |2020-12-03T21:44:38+00:00December 3rd, 2020|alerts|Comments Off on Baxter Healthcare Recalls Baxter SIGMA Spectrum Infusion Pumps with Master Drug Library (Versions 6 and 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software Due to Unplanned Shutdown Issues

Bayshore Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets

Bayshore Pharmaceuticals, LLC, Short Hills, NJ is voluntarily recalling one lot of Metformin Hydrochloride Extended-Release Tablets USP, 500 mg, 1000 count bottles and one lot of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 count bottles within expiry to the consumer level due to the detection of N-Nitrosodimethylamine (NDMA) levels above the Acceptable Daily Intake

By |2020-09-23T13:18:58+00:00August 26th, 2020|alerts|0 Comments

4e Brands North America Issues Nationwide Voluntary Recall of Hand Sanitizer

San Antonio, Texas, 4e Brands North America is voluntarily recalling ten (10) bottle sizes of Hand Sanitizers to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol). Risk Statement: Substantial methanol exposure could result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the

By |2020-09-23T12:09:46+00:00July 15th, 2020|alerts|0 Comments

Letter to Health Care Providers- Important Information on the Use of Serological (Antibody) Tests for COVID-19

The U.S. Food and Drug Administration (FDA) recommends that health care providers continue to use serological tests intended to detect antibodies to SARS-CoV-2 to help identify people who may have been exposed to the SARS-CoV-2 virus or have recovered from the COVID-19 infection. Health care providers should also be aware of the limitations of these

By |2020-09-23T12:08:46+00:00June 29th, 2020|alerts|0 Comments