Archive for the ‘FDA News’ Category
UPDATED 03/08/2010: Recall classified as Class I, expanded list of affected models. Originally posted 02/09/2010
Sheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death.
Reports of serious injuries and at least one death have been associated with increased Intraperitoneal Volume (IIPV), also known as overfill of the abdominal cavity.
Test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.
Rotor may break and eject pieces of the rotor which may cause serious physical injury to bystanders and expose them to blood-borne infectious micro-organisms.
Possible association with abnormal heart rhythms when used in combination with Norvir (ritonavir).
FDA is reviewing data from a large, long-term clinical study on possible risks for cardiovascular outcomes associated with use of rosiglitazone.
Consumers warned not to use ear candles because they can cause serious injuries, even when used according to the manufacturer’s directions.
FDA requires risk management plan and class-labeling changes for all LABAs.
Changes to Prescribing Information re: risk of renal impairment/failure, hepatic impairment/failure or gastrointestinal hemorrhage.