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.
Category: Recalls & Advisories
Recalls & Advisories
Latest
Recalls & Advisories
Latest
FDA Revises Temperature Rules on Storing, Transporting COVID-19 Vaccines
The US FDA is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be...
Recalls & Advisories
Latest
FDA: Administer COVID-19 Vaccines as Directed
The US FDA warned healthcare providers to administer the COVID-19 vaccines from Moderna and Pfizer as authorized, not to halve doses or delay second shots.
FDA Alert: Neuromuscular Blocking Agents Missing Cap Warnings
The drugs — Vecuronium bromide and rocuronium bromide — are commonly used to provide muscle relaxation during surgery or mechanical ventilation.
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FDA Issues Alert for Potential False Negatives for Abbott COVID-19 Test
The US FDA issued a public alert that the Abbott ID Now point-of-care test may return false negative results for COVID-19 patients.
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FDA lifts injunction on Philips AED defibrillators in US
Philips reports that its Emergency Care and Resuscitation business is resuming manufacturing and shipping of external defibrillators for the US.
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FDA Issues Warning Over Hydroxychloroquine, Chloroquine Side Effects
The US FDA has issued a Drug Safety Communication regarding known side effects of hydroxychloroquine and chloroquine, including serious and potentially life-threatening heart rhythm problems.
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FDA to Fast-track Potential Coronavirus Antivirals
The US FDA will fast-track potential antiviral medications to treat coronavirus, President Donald Trump announced at a White House briefing Thursday.
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FDA Slaps Black Box Warning on Singulair over Serious Mental Health Side Effects
“Because of the risk of mental health side effects, the benefits of montelukast may not outweigh the risks in some patients, particularly when the symptoms of disease may be mild and adequately treated with other medicines,” the FDA said.
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Class I Recall for King Vision Video Laryngoscope Adapter
The affected video adapters will show a reversed image on the display, which may lead to serious adverse health events, including airway trauma.
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Class I Recall for Teleflex Comfort Flo Humidification Systems
According to the FDA, there is a risk for water to flood the column and enter the circuit in the system, then enter the nose and lungs of the patient.
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Class I Recall for ResMed Stellar 100/150 Ventilators
According to the FDA, the sound alarm for ResMed’s Stellar 100 and Stellar 150 noninvasive/invasive ventilators may fail in certain circumstances.
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Class I Recall for Some GE Healthcare Carescape Respiratory Modules
GE Healthcare is recalling some Carescape Respiratory Modules and Airway Gas Option due to a manufacturing issue which may cause the devices to display incorrect oxygen values, according to an alert from the FDA.
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Teleflex Recalls Babi.Plus Pressure Relief Manifold Used for Bubble CPAP
Teleflex Inc has issued a recall for certain lots of the GaleMed Babi.Plus 12.5 cm H2O Pressure Relief Manifold, which is most commonly used for bubble CPAP therapy.
Read MoreJuul Warned Over Claims E-Cigarette Safer Than Smoking
Federal health authorities on Monday blasted vaping company Juul for illegally pitching its electronic cigarettes as a safer alternative to smoking and ordered the company to stop making unproven claims for its products. The...
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