The first standalone at-home sample collection kit that can be used with certain authorized tests. Any negative test results that are not consistent with a patient's clinical signsĪnd symptoms or necessary for patient management should be confirmed with anotherĪn emergency use authorization for the Everlywell COVID-19 Test Home Collection Kit, There have been 15 adverse event reports suggesting that some users are receiving inaccurate negative results. The drug in treating severe COVID-19 currently outweigh its known and potential risks.Īn alert that early data suggest potential inaccurate results from using the Abbott ID NOW point-of-care test to diagnoseĬOVID-19. Severe disease, defined as low blood oxygen levels or need for oxygen therapy or mechanical ventilation.īased on the evidence, the FDA determined that the known and potential benefits of and administeredīy clinicians, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in patients hospitalized with The authorization allowed the drug to be distributed in the U.S. Affected products were distributed nationwide.Īn emergency use authorization for the investigational antiviral drug remdesivir. due to the presence of particulate matter identified as iron oxide. 1, 2016, to MayĪ recall of one lot of lactated Ringer's injection USP (1,000 mL) by ICU Medical Inc. Affected devices were distributed from Feb. Of 33 medical device reports were identified, 22 related to device malfunction andġ1 related to injuries. A total ofĤ,924 recalled devices were distributed from March 1, 2018, to April 1, 2020.Ī class I recall of the auto-registration feature of the StealthStation DBS Software by Medtronic due to inaccuracies caused by minor patient movements when used with NexFrame during a deep brain stimulation procedure. Includes both the strain relief screw breaking and outflow graft tears. There have been 92 complaints related to the pre-implant pump assembly process, which Relief by Medtronic due to risk of breaks and tears during setup. Recalled devices were distributed from July 12, 2019, to March 10, 2020.Ī class I recall of the HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain There have been eight complaints and no reports of injury or death. A total of 19,400 recalled devices were distributedĪ class I recall of Langston Dual Lumen Catheters by Vascular Solutions Inc. There have been 46 complaints and three medical device reports regarding this issueīut no reports of injury or death. The OTW Latis Cleaning Catheters by Applied Medical due to risk of separation during use. Affected products were distributed nationwide.Ī class I recall of Python Embolectomy Catheters, Bard Embolectomy Catheters, and There have been two reports of adverse events related to the recall. The product may have up to 115% of the labeled amount of liothyronine (T3). Recalled products were distributed nationwide on a patient-specific prescriptionĪ recall of 13 lots of thyroid tablets USP (NP Thyroid 30 mg, 60 mg, and 90 mg) by Acella Pharmaceuticals LLC due to superpotency. The manufacturer has received 33 reports of increased heart rate, retention of water, dizziness, and low blood pressure. ![]() The FDA said it will assess whether the recalls will result in shortages and will work with manufacturers to ensure appropriate testing while preventing orĪ recall of one lot of finasteride (1.25 mg) by MasterPharm LLC because the capsules have been found to contain undeclared minoxidil. Of 14 lots of metformin hydrochloride extended-release tablets USP (500 mg and 750 each recalled one lot of metformin hydrochlorideĮxtended-release tablets USP (500 mg), and Teva Pharmaceuticals USA Inc. Due to this issue, Marksans Pharma Limited, ![]() ![]() Amneal Pharmaceuticals LLC also recalled all lots of metformin hydrochloride extended-release tablets (500 mg and 750 mg) due to detection of NDMA. A recall of all lots of metformin hydrochloride extended-release tablets USP (500 mg) by Apotex Corp due to the detection of N-nitrosodimethylamine (NDMA), a probable human carcinogen.
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