The use of affected product may cause serious adverse health consequences, including death.
11/27/2015 5:00:00 AM
Consumption of this product may result in vitamin D toxicity, which may be severe and may lead to life-threatening outcomes if left untreated.
11/25/2015 5:00:00 AM
Serious adverse events reported, including pulmonary embolism, pulmonary infarction, myocardial embolism, myocardial infarction, embolic stroke, tissue necrosis, and death.
11/23/2015 2:00:00 PM
Labels of all iodinated contrast media (ICM) products will include information about these cases. No changes to current prescribing, administration, or monitoring practices are recommended.
11/17/2015 3:00:00 PM
If failure occurs, and the operator does not intervene, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death.
11/14/2015 4:55:00 AM
Identified facility violations could result in an increased risk of infection transmission.
11/13/2015 7:10:00 PM
FDA review determines that long-term use of clopidogrel does not increase/decrease overall risk of death in patients with, or at risk for, heart disease, and does not suggest that clopidogrel increases risk of cancer/death from cancer.
11/6/2015 4:30:00 PM
Seal failure could result in patient blood loss.
10/29/2015 6:20:00 PM
If a patient experiencing a serious allergic reaction (i.e., anaphylaxis) does not receive the intended dose, there could be significant health consequences, including death.
10/29/2015 12:50:00 PM
Drug labels for Comtan and Stalevo will remain unchanged.
10/26/2015 2:40:00 PM
Cases of hepatic decompensation and liver failure in patients with underlying liver cirrhosis who were taking these medicines.
10/22/2015 7:25:00 PM
Prescribers and patients should consider separating Kayexalate dosing from other medications taken by mouth by at least 6 hours.
10/22/2015 4:58:00 PM
If there is a contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.
10/21/2015 12:00:00 PM
Potential for contaminated water to transmit bacteria through the air (aerosolize) through the device’s exhaust vent into the environment and to the patient.
10/15/2015 5:00:00 PM
If the product is taken at the maximum labeled dose, or with other medications containing acetaminophen, it may lead to liver toxicity or liver failure.
10/15/2015 11:20:00 AM
FDA is working to design clinical studies to fully evaluate reduced valve leaflet motion. At this time, FDA believes that bioprosthetic aortic valves remain reasonably safe and effective when used according to their approved indications.
10/5/2015 6:40:00 PM
Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.
10/3/2015 4:00:00 AM
Acute fracture and emergency revision surgery is a serious adverse health consequence and could lead to neurovascular damage, hematoma, hemorrhage, or death.
10/2/2015 7:25:00 PM
Clutch mechanism may fail to disengage if proper use, patient considerations, and device selection are not followed in accordance with the manufacturer’s instructions for use.
9/28/2015 6:30:00 PM
If the sterility of a compounded preparation intended to be sterile is compromised, patients may be at risk.
9/24/2015 1:15:00 PM
FDA revised the labels to indicate that each vial contains Avycaz 2.5 gram, equivalent to ceftazidime 2 gram and avibactam 0.5 gram.
9/22/2015 2:30:00 PM
Ultra-rapid metabolizers are more likely to have higher-than-normal amounts of the active form of the opioid in their blood after taking tramadol, which can result in breathing difficulty that may lead to death.
9/21/2015 3:00:00 PM
If the device stops pumping, the patient will lose consciousness almost immediately, which can lead to serious injury or death.
9/18/2015 3:48:00 PM
Testing has found that these products contain high levels of lead and/or mercury, which can cause serious health problems.
9/17/2015 11:00:00 PM
If scope reprocessing procedure is not followed meticulously, the flexible bronchoscope can remain contaminated, potentially resulting in infection transmission from one patient to the next.
9/17/2015 3:00:00 PM