Archive | February, 2010
OneTouch SureStep Test Strips (LifeScan): Recall
Test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.
Continue reading...StatSpin Express 4 Centrifuges Model 510: Class I Recall
26. February 2010
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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.
Continue reading...Invirase (saquinavir): Ongoing safety review of clinical trial data
23. February 2010
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Possible association with abnormal heart rhythms when used in combination with Norvir (ritonavir).
Continue reading...Avandia (rosiglitazone): Ongoing Review of Cardiovascular Safety
22. February 2010
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FDA is reviewing data from a large, long-term clinical study on possible risks for cardiovascular outcomes associated with use of rosiglitazone.
Continue reading...Ear Candles: Risk of Serious Injuries
20. February 2010
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Consumers warned not to use ear candles because they can cause serious injuries, even when used according to the manufacturer’s directions.
Continue reading...Exjade (deferasirox): Boxed Warning
18. February 2010
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Changes to Prescribing Information re: risk of renal impairment/failure, hepatic impairment/failure or gastrointestinal hemorrhage.
Continue reading...Maalox Total Relief and Maalox Liquid Products: Medication Use Errors
17. February 2010
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Consumers who have a history of gastrointestinal ulcers or a bleeding disorder should not use Maalox Total Relief because it contains bismuth subsalicylate, a substance chemically related to aspirin.
Continue reading...Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp: Drug Safety Communication
16. February 2010
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FDA requires REMS that ensures that only those hospitals and healthcare professionals who have enrolled and completed training in risk management program will prescribe and dispense ESAs to patients with cancer.
Continue reading...BD Q-Syte Luer Access Devices: Recall
9. February 2010
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Device may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death.
Continue reading...BD Q-Syte Luer Access Devices: Recall
9. February 2010
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Device may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death.
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26. February 2010
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