Those with weakened immune system or chronic lung disease may be more susceptible to infections with B. cepacia.
Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. Posted 10/25/2014
Risk of allergic reactions, from mild irritation or hives to serious reactions such as anaphylaxis that may be life-threatening.
Salmonella can cause serious and sometimes fatal infections in young children frail or elderly people, and others with weakened immune systems. Posted 10/20/2014
Injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response to the particulate or microembolic effects.
September 2014 Drug Safety Labeling Changes includes 55 products with revisions to Prescribing Information.
A puncture in the primary container may be difficult to detect and lead to contamination, compromised sterility, and other adverse events.
The mismatch of these devices could contribute to a delay in resuscitation and may contribute to subsequent death.
FDA analysis found these products to contain undeclared Sibutramine, which may increase blood pressure and/or pulse rate, and may also interact in life-threatening ways with other medications.
Use of the affected product may cause serious adverse health consequences, including death.
Ventilator shut-off from power failures may lead to serious patient injury or death.
Patients in Oregon and Washington may be at risk of serious infections which may be life threatening.