Safety Alerts & Recalls

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The FDA Warns About Possible Risk of Severe Liver Injury with Dronedarone (Multaq)
The Food and Drug Administration (FDA) notified healthcare professionals and patients about cases of rare, but severe liver injury, including two cases of acute liver failure leading to liver transplant in patients treated with the heart medication dronedarone (Multaq). Information about the potential risk of liver injury from dronedarone (Multaq) is being added to the Warnings and Precautions and Adverse Reactions sections of the dronedarone (Multaq) prescribing information. Dronedarone is sold under the brand name Multaq and is a drug used to treat patients who have had an abnormal heart rhythm during the past six months. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm240011.htm
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Bristol-Myers Squibb Recalls Additional Avalide Tablets
Following on from a recall in September last year, Bristol-Myers Squibb Co. has recalled another 65 more lots of its blood pressure medicine Avalide based on worries that the combination pills aren't delivering proper amounts of one active ingredient, irbesartan. Although the company has not received reports of safety problems and has not found evidence that the tablets are less effective at lowering blood pressure, the company has issued the recall because they are unable to rule out that possibility. This expanded recall may result in a shortage of Avalide over the coming weeks. Since Avalide is a combination of two medicines, irbesartan and hydrochlorothiazide, patients may be dispensed Avapro (irbesartan) plus Hydrochlorothiazide (HCTZ) as two separate medicines if supplies are disrupted. To support patients in the United States, Bristol-Myers Squibb Co. announced that it will make vouchers available to help defray the cost of hydrochlorothiazide. For information about this recall, please visit: http://www.reuters.com/article/idUSTRE70C6QU20110113 and http://online.wsj.com/article/BT-CO-20110114-707672.html To learn about the voucher program, please visit: http://www.avapro-avalide.com/
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Date Published Title Drug Source
2011-01-16 The FDA Warns About Possible Risk of Severe Liver Injury with Dronedarone (Multaq) Dronedarone FDA
2011-01-15 Bristol-Myers Squibb Recalls Additional Avalide Tablets Hydrochlorothiazide with Irbesartan Manufacturer
2011-01-13 The FDA Takes New Steps Aimed at Cutting Risks of Severe Liver Injury from Acetaminophen Pentazocine Hydrochloride with APAP FDA
2011-01-11 Reports of Accidental Overdose With Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) Morphine FDA
2011-01-11 Novo Nordisk, Inc. A Recalls Single Lot of GlucaGen Hypokit Emergency Kit Glucagon FDA
2011-01-10 Sandoz Inc. Recalls Several Lots of Lorazepam Tablets Lorazepam FDA
2011-01-10 Sandoz Inc. Recalls Single Lot of Carvedilol Tablets Carvedilol FDA
2011-01-10 Teva Pharmaceuticals Inc. Recalls Several Lots of ProAir HFA Albuterol FDA
2011-01-06 Teva Recalls Single Lot of Metronidazole 250 mg Tablets Metronidazole Manufacturer
2011-01-03 Recall - Mislabeled Unit Dose Vials Albuterol Sulfate Inhalation Solution 0.083%, 3 mL Albuterol FDA
2010-12-24 Recombinant Human Growth Hormone (Somatropin): FDA Conducting Ongoing Safety Review Somatropin FDA
2010-12-21 Pfizer Recalls More Bottles of Lipitor Over Strange Smell Atorvastatin Manufacturer
2010-12-20 FDA Publishes Drug Safety Communication: Abnormal Heart Rhythms Associated With Use of Anzemet (Dolasetron Mesylate) Dolasetron FDA
2010-12-16 FDA Begins Process To Remove Breast Cancer Indication From Avastin Prescribing Information Label Bevacizumab FDA
2010-12-14 Accidental Ingestion of Benzonatate (Tessalon) By Children Can Result in Serious Adverse Effects Benzonatate FDA
2010-12-13 Reese Pharmaceutical Company Recalls Certain Over-The-Counter Cold Relief Products That Are Mislabeled Guaifenesin Manufacturer
2010-12-10 McNeil Now Recalls All Lots of Three Rolaids Heartburn Products Calcium Carbonate with Magnesium Hydroxide Manufacturer
2010-12-02 Johnson and Johnson Recalls Several Mylanta and AlternaGel Liquid Products FDA
2010-11-29 McNeil Issues Another Recall: Tylenol Cold Multi-Symptom Liquid Products Tylenol Cold Multisymtom Plus Coug Manufacturer
2010-11-29 Teva Recalls Single Lot of Tamoxifen Tamoxifen FDA
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