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FDA MedWatch Safety Alerts

Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
Posted: August 18, 2017, 7:30 pm
UPDATED 08/18/2017. Recall issued for all lots of all compounded injectable prescription medications. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death.
Posted: August 18, 2017, 3:00 pm
Thrombus may form inside the device after implantation. Thrombosis or occlusion may lead to serious adverse health consequences, including death.
Posted: August 16, 2017, 4:00 pm
Significant probability of serious health consequences if more than the prescribed dose is dispensed, including: drowsiness causing trauma; increased anxiety; and risk of accidental injury to self or others.
Posted: August 16, 2017, 11:00 am
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.
Posted: August 10, 2017, 8:00 pm
Five reports of unanticipated deaths that occurred from 2016 to present, in patients with liquid-filled intragastric balloon systems used to treat obesity.
Posted: August 10, 2017, 3:00 pm
Advisory due to Burkholderia cepacia contamination and the potential for severe patient infection.
Posted: August 8, 2017, 4:00 am
Exposure to lead can cause serious damage to the central nervous system, the kidneys and the immune system.
Posted: August 4, 2017, 9:25 pm
UPDATED 08/04/2017. Class I Recall issued. Risk of failure of the device to initiate therapy.
Posted: August 4, 2017, 4:17 pm
Drug products, including FDA-approved products, containing polyethylene glycol castor oil have been associated with severe and sometimes fatal hypersensitivity reactions.
Posted: August 4, 2017, 3:30 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.
Posted: August 3, 2017, 5:10 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.
Posted: July 31, 2017, 5:20 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.
Posted: July 31, 2017, 4:00 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.
Posted: July 28, 2017, 8:20 pm
Unintentional dosing with Cyclobenzaprine HCl may potentially lead to the development of life-threatening serotonin syndrome, and other serious adverse events.
Posted: July 28, 2017, 2:45 pm
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
Posted: July 25, 2017, 10:44 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.
Posted: July 25, 2017, 7:00 pm
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.
Posted: July 24, 2017, 2:30 pm
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.
Posted: July 21, 2017, 3:25 pm