Two patients died 3-4 days after receiving an appropriate dose of the drug. Posted 06/18/2013
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6/18/2013 4:00:00 PM |
Use of this recalled product may cause serious adverse health consequences, including death. Posted 06/18/2013
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6/18/2013 2:30:00 PM |
Many medical devices contain configurable embedded computer systems that can be vulnerable to cybersecurity breaches.
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6/17/2013 6:27:00 PM |
MedWatch May 2013 drug safety labeling changes
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6/13/2013 10:15:00 PM |
Ingestion of a greater than intended dose of Warfarin, could lead to an increased pharmacological effect of warfarin. As a result, patients would be more likely to develop bleeding and in some patients that bleeding into a critical organ could be fatal.
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6/12/2013 10:23:00 PM |
Excessive high flow rates, presents a risk of patient toxicity and serious injury (e.g., seizure, dysrhythmia, death) due to the rapid influx of medication particularly in patients with low body mass or advanced age.
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6/12/2013 9:30:00 PM |
Testing revealed the product contains Sibutramine, which may increase blood pressure or interact, in life-threatening ways, with other medications a consumer may be taking.
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6/11/2013 8:00:00 PM |
The elevated impurity result has the potential to result in prolonged neuromuscular blockade for critically ill
patients with renal failure.
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6/10/2013 8:00:00 PM |
Users may accidentally swallow or choke on dislodged washer, which can lead to serious adverse health consequences or death.
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6/3/2013 7:05:00 PM |
Use of a compromised product may put patients at risk for serious and possible life threatening infections.
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5/30/2013 7:40:00 PM |
Prolonged use to stop pre-term labor may cause bone changes in exposed babies.
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5/30/2013 7:00:00 PM |
Administration of glass particulate can lead to serious adverse events, including life-threatening thromboembolism.
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5/29/2013 4:55:00 PM |
Reports of adverse events are all from patients who received preservative free methylprednisolone acetate (80 mg/mL) by injection.
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5/24/2013 6:06:00 PM |
Inner delivery catheter breakage can lead to vascular occlusion, thrombosis, amputation, possible cardiac arrest, or death.
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5/24/2013 3:30:00 PM |
Particulate matter in parenteral drugs has been recognized as a potential health hazard.
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5/21/2013 10:05:00 AM |
Incorrect test results at extremely high blood glucose levels.
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5/20/2013 6:00:00 PM |
If a drug product marketed as sterile has microbial contamination, patient is at risk of serious infection.
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5/18/2013 7:51:00 PM |
Patients are at increased risk of infection in the event a sterile product is compromised.
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5/17/2013 7:55:00 PM |
Risk of serious or life-threatening allergic reaction.
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5/9/2013 8:00:00 PM |
These products should not be administered to patients. If a drug product marketed as sterile has microbial contamination, it potentially places patients at risk of serious infection.
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5/8/2013 9:45:00 PM |
Undeclared tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
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5/8/2013 1:30:00 PM |
Testing revealed the product contains tadalafil, which may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels.
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5/7/2013 9:30:00 PM |
Testing revealed the product contains an analogue of sildenafil, which may interact with nitrates found in prescription drugs such as nitroglycerin, and lower blood pressure to dangerous levels.
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5/7/2013 9:15:00 PM |
May result in unexpected ventilator shut downs, which can result in serious adverse health consequences, including death.
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5/7/2013 8:45:00 PM |
Use of lead cap may cause lead damage. Lead replacement may be required or optimal therapy may not be provided.
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5/7/2013 6:30:00 PM |
