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Pomona, California, Volt Candy is voluntarily recalling one lot of PrimeZen Black 6000, 2000 mg capsule, to the consumer level. FDA analysis has found PrimeZen Black 6000 capsules to be tainted with sildenafil & tadalafil. Sildenafil and tadalafil are phosphodiesterase (PDE-5) inhibitors found in FD
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FDA Roundup: February 10, 2023
FDA Roundup: February 10, 2023
http://www.fda.gov/news-events/press-announcements/fda-roundup-february-10-2023
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Universal Meditech Inc. Issues Nationwide Recall of Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit
Universal Meditech Inc. initiated a nationwide recall of 56,300 Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits. The product(s) have been found to have been distributed without appropriate premarket clearance or approval which potentially could result in inaccurate test results due to lack o
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Do Not Use Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test: FDA Safety Communication
The FDA is warning people not to use the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Tests. The test’s performance has not been adequately established.
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Universal Meditech Inc. Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA
Universal Meditech Inc. recalls unauthorized COVID-19 Direct Antigen Rapid Tests because they are not authorized, cleared, or approved by the FDA.
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FDA Roundup: February 7, 2023
FDA Roundup: February 7, 2023
http://www.fda.gov/news-events/press-announcements/fda-roundup-february-7-2023
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2021 Safety Communications
The FDA posts Medical Device Safety Communications to describe the FDA’s current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.
http://www.fda.gov/medical-devices/safety-communications/2021-safety-communications
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Updated: Mammography Problems at Advanced Women Imaging in Guttenberg, NJ
The U.S. Food and Drug Administration (FDA) is alerting patients who had mammograms at Advanced Women Imaging, located in Guttenberg, NJ, on or after March 11, 2020, about possible problems with the quality of their mammograms.
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FDA Roundup: February 3, 2023
FDA Roundup: February 3, 2023
http://www.fda.gov/news-events/press-announcements/fda-roundup-february-3-2023
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Global Pharma Healthcare Issues Voluntary Nationwide Recall of Artificial Tears Lubricant Eye Drops Due to Possible Contamination
Global Pharma Healthcare is voluntarily recalling all lots within expiry of their Artificial Tears Lubricant Eye Drops, distributed by /EzriCare, LLC- and Delsam Pharma, to the consumer level, due to possible contamination.