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August 10, 2017 at 4:00 PM
Common side effects of bupropion include: nausea, vomiting, dry mouth, headache, constipation, sweating, sore throat, diarrhea, dizziness, restlessness, blurry vision. Risk of allergic reactions are possible and could be life threatening.
August 10, 2017 at 11:00 AM
Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death.
August 10, 2017 at 11:00 AM
Five reports of unanticipated deaths that occurred from 2016 to present, in patients with liquid-filled intragastric balloon systems used to treat obesity.
August 08, 2017 at 12:00 AM
Advisory due to Burkholderia cepacia contamination and the potential for severe patient infection.
August 04, 2017 at 5:25 PM
Exposure to lead can cause serious damage to the central nervous system, the kidneys and the immune system.
August 04, 2017 at 12:17 PM
UPDATED 08/04/2017. Class I Recall issued. Risk of failure of the device to initiate therapy.
August 04, 2017 at 11:30 AM
Drug products, including FDA-approved products, containing polyethylene glycol castor oil have been associated with severe and sometimes fatal hypersensitivity reactions.
August 03, 2017 at 1:10 PM
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.
July 31, 2017 at 1:20 PM
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.
July 31, 2017 at 12:00 PM
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.
July 28, 2017 at 4:20 PM
Patients had diminished visual function and adverse reactions after injection into the vitreous of the eye at the end of the cataract surgery procedure.
July 28, 2017 at 10:45 AM
Unintentional dosing with Cyclobenzaprine HCl may potentially lead to the development of life-threatening serotonin syndrome, and other serious adverse events.
July 25, 2017 at 6:44 PM
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
July 25, 2017 at 3:00 PM
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.
July 24, 2017 at 10:30 AM
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.
July 21, 2017 at 11:25 AM
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.
July 21, 2017 at 11:00 AM
Fujifilm issued an Urgent Medical Device Correction and Removal notification, informing customers of its voluntary recall of all ED-530XT duodenoscopes.
July 12, 2017 at 2:33 PM
Consumption of these products may cause elevated blood pressure, aggressive behavior, male infertility, or enlarged breasts and shrinkage of the testes in men.
July 06, 2017 at 2:30 PM
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.
July 06, 2017 at 2:00 PM
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.
July 06, 2017 at 9:00 AM
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.
July 06, 2017 at 12:00 AM
UPDATED 07/21/2017. Recall Classified as Class I. For pacing dependent patients, an interruption of pacing system could result in serious injury or death if not detected.
June 27, 2017 at 12:00 AM
Reasonable probability that the patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis.
June 23, 2017 at 3:30 PM
Reasonable probability that patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis.