Use associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient.
Administration of a drug product intended to be sterile that is compromised can result in health hazards including risk of serious infection or other complications.
Risk of surgical intervention to retrieve a separated segment, or other serious adverse health consequences such as internal organ injury, stroke, kidney failure, intestinal failure, and death.
Reports of hair loss, hair breakage, balding, itching, and rash.
The agency confirmed the product has been contaminated with Burkholderia Cepacia, a bacteria linked to an outbreak in five states.
Alere is working with the FDA to determine the most appropriate timing for product discontinuation and will provide guidance on transitioning patients to an alternate solution.