Mislabeled product could expose the consumer or their pet(s) to potential overdosing that can cause severe intoxication which may lead to cardiogenic shock, renal failure, coma or death.
4/21/2017 6:10:00 PM
New and strengthened WARNINGS and CONTRAINDICATIONS on drug labels describing serious risks, including slowed or difficult breathing and death.
4/20/2017 3:30:00 PM
Use of these products may pose a threat to consumers because the undeclared ingredients may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels.
4/19/2017 12:55:00 PM
If left untreated, under-drainage can potentially lead to coma and death.
4/9/2017 1:29:00 AM
Voluntary recall of all lots of sterile products, to the hospital/user level.
4/6/2017 8:35:00 PM
Potential for ventilator reset during normal operation, without an accompanying alarm.
4/5/2017 5:40:00 PM
Failure to activate or increased force needed to activate may have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis).
3/31/2017 11:00:00 PM
Tip could enter the patient's bloodstream, resulting in prolonged procedure times, additional surgery to remove the tip from the patient, blood clots, internal tears and perforation to arteries or veins, excessive bleeding, and death.
3/31/2017 5:30:00 PM
Sibutramine may 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.
3/30/2017 1:50:00 PM
A delay in delivering therapy could result in serious patient injury such as permanent organ damage, brain injury, or death.
3/24/2017 5:20:00 PM
BIA-ALCL is a rare condition; when it occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma.
3/21/2017 5:00:00 PM
Increased rate of major adverse cardiac events observed in patients receiving the BVS, when compared to patients treated with metallic XIENCE drug-eluting stent.
3/18/2017 2:00:00 PM
Patients who do not have a gallbladder should not take Viberzi. Developing pancreatitis could result in hospitalization or death.
3/15/2017 4:02:00 PM
Patients may receive a drug overdose or under dose which can lead to serious adverse health consequences such as respiratory depression, coma or death.
3/14/2017 5:20:00 PM
Device has shut down unexpectedly during patient treatment, which may expose patients to the risk of serious harm or death. Posted 01/14/2017
3/9/2017 7:23:00 PM
Nationwide recall of Regeneca's entire line of herbal and dietary supplement products.
3/9/2017 6:40:00 PM
Laboratory results confirmed contamination with Pantoea and Enterococcus (intrinsically vancomycin-resistant) bacteria.
3/9/2017 4:00:00 PM
Procedure may put patients at risk because is being promoted as treatment for a variety of conditions even though it has not been formally studied in clinical trials
3/8/2017 6:30:00 PM
PDE-5 Inhibitors may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
3/8/2017 1:00:00 AM
Loss of container closure integrity could impact the product’s sterility assurance and may lead to serious adverse events such as infections, both localized at the site of injection and systemically.
2/27/2017 6:00:00 PM
Risk of potential adverse events can range from local site reactions including swelling and inflammation, to allergic reactions which could be life-threatening to users who are sensitive to latex.
2/25/2017 1:00:00 AM
Undeclared tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
2/22/2017 1:00:00 PM
Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.
2/16/2017 2:30:00 PM
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
2/15/2017 1:30:00 PM
Faulty Air-In-Line sensor which may generate a false alarm, and cause the syringe pump to stop supplying the infusion to the patient. Interruption of infusion could lead to serious adverse health consequences or death.
2/9/2017 4:00:00 PM