Drug products, including FDA-approved products, containing polyethylene glycol castor oil have been associated with severe and sometimes fatal hypersensitivity reactions.
Use 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.
Use of product found to contained undeclared Sildenafil could result in death. The groups affected include men with diabetes, high blood pressure, high cholesterol, or heart disease.
Injection of particulate matter could potentially lead to limited adverse events such as allergic reactions, local irritation and inflammation in organs or tissues, or other serious adverse health consequences.
Patients had diminished visual function and adverse reactions after injection into the vitreous of the eye at the end of the cataract surgery procedure.
Unintentional dosing with Cyclobenzaprine HCl may potentially lead to the development of life-threatening serotonin syndrome, and other serious adverse events.
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
Sibutramine is known to increase blood pressure and/or pulse rate in some patients and may present a risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Consumers with diabetes, hypertension, high cholesterol or heart disease often take nitrates; concomitant use of nitrates and PDE-5 can lead to fatal cardiovascular collapse.
Fractured pieces of the delivery wire could be left inside the patient’s brain bloodstream. This or the attempts made to retrieve the fractured pieces can lead to serious adverse health consequences.
Fujifilm issued an Urgent Medical Device Correction and Removal notification, informing customers of its voluntary recall of all ED-530XT duodenoscopes.
Consumption of these products may cause elevated blood pressure, aggressive behavior, male infertility, or enlarged breasts and shrinkage of the testes in men.
Using a device with a cracked/broken cartridge holder may result in the device delivering a reduced dose of insulin which could potentially lead to high blood sugar.
UPDATED 07/06/2017. Voluntary recall closed on June 23, 2017. FDA continues to recommend that health care providers discuss with their patients all available treatment options for CEA surgery.
Consumption of products containing derivatives of anabolic steroids may cause serious liver injury and other adverse health consequences, including kidney injury, increased risk of heart attack and stroke.
For pacing dependent patients, an interruption of pacing system could result in serious injury or death if not detected. Posted 07/06/2017