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FDA MedWatch Safety Alerts
If a drug product marketed as sterile has microbial contamination, patient is at risk of serious infection.
Posted: May 18, 2013, 7:51 pm
Patients are at increased risk of infection in the event a sterile product is compromised.
Posted: May 17, 2013, 7:55 pm
UPDATED 05/14/2013. FDA has approved label changes specifying new dosing recommendations for zolpidem products.
Posted: May 14, 2013, 2:30 pm
Risk of serious or life-threatening allergic reaction.
Posted: May 9, 2013, 8:00 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.
Posted: May 8, 2013, 9:45 pm
Undeclared tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Posted: May 8, 2013, 1:30 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.
Posted: May 7, 2013, 9:30 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.
Posted: May 7, 2013, 9:15 pm
May result in unexpected ventilator shut downs, which can result in serious adverse health consequences, including death.
Posted: May 7, 2013, 8:45 pm
Use of lead cap may cause lead damage. Lead replacement may be required or optimal therapy may not be provided.
Posted: May 7, 2013, 6:30 pm
Use of these non-sterile products could increase the risk of infection in surgical patients.
Posted: May 7, 2013, 4:15 pm
Plastic packaging may become lodged in the filter potentially causing an obstruction in airflow, which may result in low blood oxygen (hypoxia), suffocation and death.
Posted: May 7, 2013, 2:15 pm
Based on a recent study, there is evidence that these medications can cause decreased IQ scores in children whose mothers took them while pregnant.
Posted: May 6, 2013, 5:20 pm
Use of the incorrect nonproprietary name for Kadcyla in some medication-related electronic systems poses a risk of mix-up with Herceptin (trastuzumab).
Posted: May 6, 2013, 2:30 pm
Laboratory analysis has found tadalafil and sildenafil.
Posted: May 2, 2013, 8:30 am
UPDATED 05/01/2013. Damage from battery leakage may cause the device to shut off without warning.
Posted: May 1, 2013, 9:03 pm
The screen on the ventilator may indicate that the Power Pac battery is fully charged when it is not, or the unit may switch to backup battery power as soon as it is removed from AC power.
Posted: May 1, 2013, 8:40 pm
The platelet container is incorrectly labeled as “AS-1 Red Blood Cell Adenine-Saline added”.
Posted: April 30, 2013, 11:45 pm
An increased risk of liver injury was observed in recent large clinical trials evaluating Samsca.
Posted: April 30, 2013, 5:30 pm
Administration of precipitated Piperacillin/Tazobactam can lead to serious adverse events.
Posted: April 30, 2013, 1:35 pm