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FDA MedWatch Safety Alerts

Reports of serious clinical consequences, such as over- and under- infusion of high risk or life-sustaining medications, occlusion detection failures, inadvertent boluses caused by inconsistent fluid delivery, and other malfunctions.
Posted: August 25, 2016, 4:00 pm
Klebsiella pneumoniae contamination, if present in the product, may result in infections that may be sight-threatening.
Posted: August 22, 2016, 3:45 pm
Administered of metal particulate may result in serious adverse events such as stroke, heart attack, respiratory failure, kidney failure, or liver failure.
Posted: August 19, 2016, 5:00 pm
Risk of sub-therapeutic dose as well as potential microbial contamination.
Posted: August 18, 2016, 6:20 pm
UPDATED 8/16/2016. Recall expanded to include an additional lot. Product with B. cepacia may cause serious, life-threatening infections in patients whose bodies cannot fight disease or in hospitalized patients, as well as certain other patient groups.
Posted: August 17, 2016, 6:15 pm
Health care facilities should have transitioned to alternative methods of reprocessing of duodenoscopes. System 83 Plus AERs remain in service for the reprocessing endoscopes other than duodenoscopes.
Posted: August 17, 2016, 1:30 pm
Potential adverse events that may occur as a result of this contamination could include vessel damage, bleeding and embolic particulate in the circulatory system.
Posted: August 15, 2016, 9:00 pm
The detection problem could lead to a risk of false negative or invalid results for clinical laboratory tests. The use of the affected product may cause serious adverse health consequences, including death.
Posted: August 12, 2016, 11:20 pm
Tablets have the potential to be contaminated with elevated levels of lead, a naturally occurring element which can affect multiple body system and particularly harmful to young children.
Posted: August 12, 2016, 6:00 pm
Use of B. cepacia contaminated product could result in serious or life-threatening infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.
Posted: August 9, 2016, 12:00 pm
Administration to a patient may result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or low-level allergic response to the particulate.
Posted: August 5, 2016, 5:20 pm
Risk of serious health consequences, including excessive carbon dioxide in the bloodstream (hypercapnia) and increased acidity in the blood (acidosis), which could lead to death.
Posted: August 5, 2016, 1:00 pm
Administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling, and blockage or clotting in blood vessels, which may be life-threatening if a critical organ is affected.
Posted: August 3, 2016, 12:30 pm
Ventilator shutdown may cause serious adverse health consequences, including death.
Posted: July 28, 2016, 6:20 pm
Use associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient.
Posted: July 26, 2016, 4:01 pm
Administration of a drug product intended to be sterile that is compromised can result in health hazards including risk of serious infection or other complications.
Posted: July 22, 2016, 6:15 pm
Risk of surgical intervention to retrieve a separated segment, or other serious adverse health consequences such as internal organ injury, stroke, kidney failure, intestinal failure, and death.
Posted: July 22, 2016, 2:00 pm
Reports of hair loss, hair breakage, balding, itching, and rash.
Posted: July 19, 2016, 5:00 pm
The agency confirmed the product has been contaminated with Burkholderia Cepacia, a bacteria linked to an outbreak in five states.
Posted: July 16, 2016, 4:00 am
Alere is working with the FDA to determine the most appropriate timing for product discontinuation and will provide guidance on transitioning patients to an alternate solution.
Posted: July 12, 2016, 7:30 pm