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MedWatch Safety Alert

Potential for False Positive Results with Abbott Molecular Inc. Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits - Letter to Clinical Laboratory Staff and Health Care Providers

False positives can occur when PCR mixture carries over into nearby assay wells. Letter provides background, recommendations, how to report problems to the FDA.


Pfizer Expands Voluntary Nationwide Recall to include All Lots of CHANTIX® (Varenicline) Tablets Due to N-Nitroso Varenicline Content

Pfizer is voluntarily recalling all lots of Chantix 0.5 mg and 1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit. As alternative suppliers have been approved in the United States, Pfizer


Potential Risk of Aluminum Leaching with Use of Certain Fluid Warmer Devices - Letter to Health Care Providers

The FDA is alerting health care providers about the use of certain fluid warmers and the potential for aluminum leaching.


2021 Biologics Recalls

Listing of the 2021 Biologics Recalls


Urgent Voluntary Recall: Level 1 Fast Flow Fluid Warming System, NORMOFLO Fluid Warmer and Level 1 Normothermic I.V. Fluid Administration Set

Level 1® Fast Flow Fluid Warming System, NORMOFLO® Fluid Warmer and Level 1® Normothermic I.V. Fluid Administration Set manufactured by Smiths Medical ASD Inc.


2021 Medical Device Recalls

List of Medical Device recalls in 2021.


Smiths Medical Recalls NORMOFLO Irrigation Fluid Warmers and Warming Sets Due to the Possibility of Harmful Levels of Aluminum Leaching into the Fluid Path of the Warmers

Smiths Medical ASD Inc is recalling the NORMOFLO Irrigation Fluid Warmer and Warmers Sets because of the potential for aluminum ions leaching into warmed fluids.


Jacobus Pharmaceutical Company Inc. Issues Voluntary Worldwide Recall of Ruzurgi® (amifampridine) 10 mg Tablets Due to Yeast, Mold, and Bacterial Contamination

Plainsboro, New Jersey, Jacobus Pharmaceutical Company Inc. is voluntarily recalling 3 lots of Ruzurgi® (amifampridine) 10 mg tablets to the consumer level. The products have been found to be contaminated with yeast, mold, and aerobic bacteria based on laboratory test results. Oral products heavily


Eight Medical International Recalls Recirculator 8.0 Disposable Lavage Kits due to Potential Exposure to High Levels of Aluminum

When used for warming therapy, the Recirculator 8.0 Disposable Lavage Kit from Eight Medical may expose patients to high levels of aluminum.