If there is a contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.
If the sterility of a compounded preparation intended to be sterile is compromised, patients may be at risk.
If there is contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.
Unapproved products may be contaminated or manufactured incorrectly, which could result in patients receiving the wrong dose, even when administered according to the labeled directions for use.
FDA will update recall with new information as it becomes available.
An interruption in electrical connection would cause the pump to stop, which could cause serious patient injury or death.
Risk of embolization, which can cause vision impairment, blindness, stroke and damage and/or death of the skin and underlying facial structures.
FDA is unable to exclude the possibility that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following intramuscular injection.
Risk of excess bone growth, fluid accumulation, inhibited bone healing, and swelling.
Adverse events include fever, chills, tremors and headache,and there is one death associated with the use of these products.
Subpotent L-citrulline in patients with certain urea cycle defects can lead to high ammonia levels, which is serious and potentially life-threatening.
FDA testing confirmed the presence of gram-positive rod bacteria in the product, which can cause infection in patients.
Use of Microbial contamination in products intended to be sterile can put patients at risk for serious, potentially life-threatening infections.
In the event a sterile product is compromised, patients are at risk for very serious infections.
If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. Posted 10/21/2013
Health care professionals should consider for each patient, whether the benefits of Iclusig treatment are likely to exceed the risks of treatment.
If microbial contamination occurs in medications intended to be sterile, patients are at risk of serious infections that may be life threatening.
If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.