Reports of hypersensitivity reactions, including anaphylaxis (a life-threatening allergic reaction), angioedema, low blood pressure, rapid heart rate, swollen tongue, difficulty breathing, wheezing, or rash.
Entries Tagged as 'FDA'
Saphris (asenapine maleate): Drug Safety Communication: Serious Allergic Reactions
September 1st, 2011 · No Comments
Tags: FDA · FDA Alerts
Reclast (zoledronic acid): Drug Safety Communication - New Contraindication and Updated Warning on Kidney Impairment
September 1st, 2011 · No Comments
Reclast should not be used in patients with creatinine clearance less than 35 mL/min or in patients with evidence of acute renal impairment.
Tags: FDA · FDA Alerts
King International Recalls the Shoulderflex Massager
August 31st, 2011 · No Comments
In cooperation with the Food and Drug Administration (FDA), King International LLC Is initiating a recall of the Shoulderflex massager due to a report of a strangulation and death. Consumers, retailers and catalog sellers are being advised to immediately stop using Shoulderflex massagers, and to safely dispose of them in the trash.
Tags: FDA · FDA Recalls
Pure Encapsulations, Inc. Issues Allergy Alert On Undeclared Egg Allergen In Prenatal Nutrients
August 31st, 2011 · No Comments
Pure Encapsulations of Sudbury, Massachusetts is voluntarily recalling PreNatal Nutrients lot number 3560111, because it may contain undeclared egg allergen. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume these products.
Tags: FDA · FDA Recalls
Vita Food Products Issues Voluntary Recall of 4 oz. Vita Classic Premium Sliced Smoked Atlantic Nova Salmon Packages with “SELL BY DEC 15 2011 01961″ Purchased on July 25 or After
August 26th, 2011 · No Comments
Vita Food Products, Inc. of Chicago, Illinois is notifying the public that 8,088 individual retail packages of 4 oz. Vita Classic Premium Sliced Smoked Atlantic Nova Salmon are being voluntarily recalled due to the potential for contamination with
Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea.
Tags: FDA · FDA Recalls