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.
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.
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.
Topical administration of a 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.
Ventilator shutdown may cause serious adverse health consequences, including death.
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.
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.
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.
Reports of hair loss, hair breakage, balding, itching, and rash.
The agency confirmed the product has been contaminated with Burkholderia Cepacia, a bacteria linked to an outbreak in five states.
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.
Sibutramine may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Batteries may lose power prematurely due to faulty cells.
Revised warnings in the drug labels to include information about acute kidney injury and added recommendations to minimize this risk.
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Majority of reported problems occurred in individuals intentionally misusing and abusing high doses of loperamide in attempts to self-treat opioid withdrawal symptoms or to achieve a feeling of euphoria.
Risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products.