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FDA Recalls and Alerts

Pfizer Announces Recall Of Birth Control

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Pfizer Inc. announced that it has voluntarily recalled 14 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol) Tablets and 14 lots of Norgestrel and Ethinyl Estradiol Tablets (generic)for customers in the U.S. market.

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Cephalon, Inc. Issues Voluntary Nationwide Recall of Treanda

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Cephalon, Inc. is voluntarily recalling Treanda® (bendamustine HCL) for Injection 25mg/8mL; lot TB30111, expiration date 12/2012. This product lot is being recalled due to the presence of particulate matter found in a single vial, which has been identified as glass fragments.

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Novartis Issues Voluntary Nationwide Recall of Certain Over-The-Counter Products

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Novartis Consumer Health, Inc. (NCH) announced that it is voluntarily recalling all lots of select bottle packaging configurations of Excedrin and NoDoz products with expiry dates of December 20, 2014 or earlier as well as Bufferin and Gas-X Prevention products with expiry dates of December 20, 2013 or earlier, in the United States. NCH is taking this action as a precautionary measure because the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets.

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The Perfect Gift for Your Former BFF

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One gift you might want to make sure is not on your list this season is the ShoulderFlex Massager. Though it might appear to be a relaxation-inducing gift, the FDA is warning to skip the dangerous device.

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Blood Thinner Pradaxa May Lead to Bleeding

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U.S. Food and Drug Administration officials are taking a second look at blood thinning drug Pradaxa (dabigatran etexilate mesylate) after reports of serious, potentially fatal, bleeding.

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FDA Revokes Approval of Breast Cancer Drug

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FDA Commissioner Margaret A. Hamburg, M.D., said she is revoking the agency’s approval of the breast cancer indication for Avastin (bevacizumab) after concluding that the drug has not been shown to be safe and effective for that use.

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Cholesterol Drug Trilipix May Not Lower Heart Risk

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U.S. Food and Drug Administration officials have announced that cholesterol-lowering drug fenofibric acid (Trilipix) might not lower a patient's risk of having a heart attack or stroke.

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FDA Focus on TNF Blockers

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A class of drugs is now under suspicion of causing cancer in children, adolescents and young adults under the age of 30. These are called Tumor Necrosis Factor (TNF) blockers, and the U.S. Food and Drug Administration (FDA) recently released an update regarding its ongoing safety review of these drugs.

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Osteoporosis Tool Approved

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A diagnostic tool for early assessment of osteoporosis has gained FDA approval. The device, called Sunlight MiniOmni, is already used in Europe, Asia, and the Middle East.

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Sepsis Drug Pulled

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U.S. Food and Drug Administration officials announced that Eli Lily and Company have voluntarily pulled Xigris (drotrecogin alfa) from all markets because the medication failed to show increased survival for patients suffering from severe sepsis in a major study.

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