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Brooklyn, New York, WEFUN Inc is voluntarily recalling 300 Boxes of WEFUN Capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil. Sildenafil is an ingredient known as a Phosphodiesterase Inhibitor (PDE-5) inhibitor found in FDA-approved products for the trea
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FDA Roundup: September 1, 2023
FDA Roundup: September 1, 2023
http://www.fda.gov/news-events/press-announcements/fda-roundup-september-1-2023
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La FDA emite cartas de advertencia a tres fabricantes de fórmula infantil
La FDA emite cartas de advertencia a tres fabricantes de fórmula infantil
http://www.fda.gov/news-events/press-announcements/la-fda-emite-cartas-de-advertencia-tres-fabricantes-de-formula-infantil
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Datascope/Maquet/Getinge Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Unexpected Shutdowns
Datascope/Maquet/Getinge recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for unexpected electrical shutdowns.
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UPDATE: Risk of Device Failures for Getinge’s Maquet/Datascope Cardiosave Intra-Aortic Balloon Pump (IABP) – Letter to Health Care Providers
Cardiosave IABP devices may unexpectedly shutdown or interrupt therapy (pump stops).
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Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Gas Loss and Gas Gain Failures
The Cardiosave IABP may stop unexpectedly due to a high priority Gas Gain or Gas Loss alarm. The alarm will interrupt therapy and require user intervention to correct and restart.
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Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Autofill Failure Alarms Resulting in Pump Stops
Cardiosave IABPs are used to inflate and deflate intra-aortic balloons. The device may stop unexpectedly due to Autofill Failure Alarms and will be put in standby mode.
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FDA Issues Warning Letters to Three Infant Formula Manufacturers
FDA Issues Warning Letters to Three Infant Formula Manufacturers
http://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-three-infant-formula-manufacturers
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FDA Roundup: August 29, 2023
FDA Roundup: August 29, 2023
http://www.fda.gov/news-events/press-announcements/fda-roundup-august-29-2023
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Dr. Berne’s Whole Health Products Issues Voluntary Nationwide Recall of Dr. Berne’s MSM Drops 5% and 15% Solution Eye Drops Due to Bacterial and Fungal Contamination
Tesuque, NM, Dr. Berne’s Whole Health Products is voluntarily recalling all lots of MSM DROPS 5%,15% Solution, Dr. Berne’s Organic Castor Oil Eye Drops and Dr. Berne’s MSM MIST 15% Solution to the consumer level.