Green Pharmaceuticals Recalls SnoreStop NasoSpray Lot
Green Pharmaceuticals Inc is voluntarily recalling lot 2373/21222 of SnoreStop NasoSpray.
Category: Recalls & Advisories
Recalls & Advisories
Latest
Recalls & Advisories
Latest
FDA Warns Against Use of Skippack Medical COVID Antigen Tests
The US FDA is warning consumers and healthcare providers to not use the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) because these tests are not authorized, cleared, or approved by the FDA.
Recalls & Advisories
Latest
FDA Orders Philips Respironics to Notify Patients of Recall for Ventilators, CPAP Devices
The FDA ordered Philips to notify patients and DMEs of the company’s June 14, 2021 recall of certain ventilators, CPAP, and BiPAP machines.
FDA Update on Trilogy Evo Recall
The FDA says an incorrect and non-specified polyester polyurethane, raw foam product, not intended for use in Trilogy Evo ventilators, was used to manufacture certain ventilators.
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FDA Signals Blood Collection Equipment Shortage
The US FDA updated the medical device shortage list to include all blood specimen collection tubes to the testing supplies and equipment – specimen collection category.
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FDA: Stop Using LuSys Laboratories COVID-19 Tests
The FDA has warned consumers to stop using the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test.
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Puritan Bennett 980 Ventilator Recall
Covidien, LP (part of Medtronic) is recalling its Puritan Bennett 980 Series Ventilator due to a capacitor manufacturing assembly error that may cause the ventilator to become inoperable or stop working as intended, according to an FDA alert.
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Temporarily-authorized Hand Sanitizers Will Need to Cease Production
The FDA will withdraw temporary authorization for companies manufacturing alcohol-based hand sanitizer as part of the COVID-19 public health crisis.
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Philips Statement on V60/V60 Plus Ventilator Recall
Philips Healthcare provided a statement in response to RT’s recent article, “Philips V60, V60 Plus HFO-equipped Ventilators Recalled Over Risk of Reduced Oxygen.”
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Philips V60, V60 Plus HFO-equipped Ventilators Recalled Over Risk of Reduced Oxygen
According to an FDA alert, Philips Respironics is recalling the V60 and V60 Plus ventilators that provide High Flow Therapy (Software Version 3.00 and Software Version 3.10) due to the risk to the patients who rely on the ventilator to provide high flow oxygen therapy if the system pressure reaches the default maximum limit.
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FDA Includes Myocarditis, Pericaditis Risks for Pfizer and Moderna vaccines
The FDA has reported increased risks of myocarditis and pericarditis following vaccination with the Moderna and Pfizer-BioNTech COVID-19 vaccine.
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FDA Okays Lower Dose of Regeneron Monoclonal Antibody Cocktail
Regeneron’s COVID-19 monoclonal antibody cocktail (casirivimab + imdevimab) is now authorized at half the dose for patients age 12 and older.
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FDA Seeks $6.5B for 2022 Budget
The US FDA has requested a total budget of $6.5 billion as part of the President’s FY22 budget — a nearly 8% increase over FY21.
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FDA Revokes EUA for Monoclonal Antibody Bamlanivimab
The US FDA has revoked an EUA for the monoclonal antibody bamlanivimab when administered alone, for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients.
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Safety Board Expresses ‘Concern’ Over AstraZeneca Vaccine Data
A Data & Safety Monitoring Board expressed concern that AstraZeneca may have included outdated information in a Phase 3 trial for its COVID-19 vaccine.
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