Safety Alerts & Recalls

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Drug Interaction Warnings Added to Prescribing Information for Seroquel
The FDA has requested that AstraZeneca add a new heart warning to the labels of its antipsychotic medicine Seroquel and the extended-release Seroquel XR. The new prescribing information label will recommend that patients should avoid use of Seroquel and Seroquel XR in combination with 12 drugs linked to abnormal heart rhythms (also known as arrhythmias). The abnormal heart rhythm, known as prolongation of the QT interval, can cause sudden cardiac arrest, a condition where the heart stops beating. The updated prescribing information lists the other drugs to avoid including: antiarrhythmic drugs like quinidine, procainamide, amiodarone (Cordarone, Nextarone, Pacerone) and sotalol (Betapace); antipsychotic drugs like ziprasidone (Geodon), chlorpromazine and thioridazine; antibiotics like gatifloxacin (Zymar, and Zymaxid) and moxifloxacin (Avelox); the anti-infective drug pentamidine (Pentam); and synthetic opioids like levomethadyl acetate and methadone (Dolophine, Methadose). The label also raises caution about use by the aged and people with heart disease. For more information, please visit: http://www.nytimes.com/2011/07/19/health/19drug.html?_r=1
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Pfizer Recalls Select Lots of Nitrostat (Nitroglycerin) Tablets, 0.4mg
Pfizer Pharmaceuticals LLC has recalled select lots of Nitrostat (Nitroglycerin) Tablets, 0.4mg, and Nitrostat (Nitroglycerin) Tablets, 0.6mg. The following lot numbers have been recalled because a bottle of Nitrostat 0.6 mg tablet was found in a carton that was suppose to contain Nitrostat 0.4 mg tablet: 1) Nitrostat (Nitroglycerin) Tablets, 0.4mg – Lot number V100670 2) Nitrostat (Nitroglycerin) Tablets, 0.6mg – Lot number V100546 Nitrostat contains the active ingredient nitroglycerin and is commonly used in the treatment of chest pain. Nitroglycerin is also sold under other brand names. This recall alert only applies to the select lot of Nitrostat 0.4mg and 0.6mg tablets. No other nitroglycerin products were involved in this recall. To view the FDA notice about this recall, please visit: http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm262090.htm
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Date Published Title Drug Source
2011-07-19 Drug Interaction Warnings Added to Prescribing Information for Seroquel Quetiapine FDA
2011-07-19 Pfizer Recalls Select Lots of Nitrostat (Nitroglycerin) Tablets, 0.4mg Nitroglycerin FDA
2011-07-19 Teva Recalls Several Lots of Hydralazine Tablets, 10 mg, 25 mg, 50 mg and 100 mg Hydralazine FDA
2011-07-19 Bayer Health Recalls Single Lot of Genuine Bayer Aspirin Aspirin FDA
2011-07-19 King Pharmaceuticals Recalls Single Lot of Cortisporin Otic Solution Otosporin FDA
2011-07-19 Teva Recalls Several Lots of Prazosin Capsules, 1 mg Prazosin FDA
2011-07-19 D.S.C. Laboratories Recalls Single Lot of Anecream Lidocaine 4% Cream Lidocaine FDA
2011-07-21 Non-Safety-Related Recall of Several Lots of Daytrana Patches Methylphenidate Manufacturer
2011-07-22 FDA Reviewing of Oral Bisphosphonates and Potential Increased Risk of Esophageal Cancer Ibandronate Sodium FDA
2011-07-22 FDA Reviewing Results of Study Multaq (Dronedarone) in Patients with Permanent Atrial Fibrillation Dronedarone FDA
2011-07-22 Reducing Fever and Relieving Pain in Children: Safe Use of Acetaminophen Acetaminophen FDA
2011-07-27 FDA Warns of Possible Serious Neurological Reactions When Methylene Blue Is Given To Patients Taking Certain Medicines for Depression, Anxiety, Bipolar Disorder, Insomnia Methylene Blue FDA
2011-07-27 FDA Warns of Possible Serious Neurological Reactions When Linezolid (Zyvox) Is Given To Patients Taking Certain Medicines for Depression, Anxiety, Bipolar Disorder, Insomnia Linezolid FDA
2011-08-01 McNeil Lowers Maximum Tylenol Dose to Prevent Overdoses Acetaminophen Manufacturer
2011-08-02 FDA Report Cites Customer Complaints of Shrink Wrap Found in Vaccine Vials Human Papilloma Virus Quadrivalent (Types 6, 11, 16, and 18) Vac FDA
2011-08-03 Vintage Pharmaceuticals Recalls Select Lots of Q-Tussin DM and Iophen DM-NR Liquid Guaifenesin with Dextromethorphan FDA
2011-08-03 Vintage Pharmaceuticals Recalls Select Lots of CODITUSS DM Liquid FDA
2011-08-03 Vintage Pharmaceuticals Recalls Single Lot of Q-Tapp DM Liquid Poly-Histine-DM FDA
2011-08-03 Hetero Drugs Limited Recalls Single Lot of Torsemide tablets, 100 mg Torsemide FDA
2011-08-03 FDA Warns: Risk of Birth Defect with Long-Term, High-Dose Fluconazole During Pregnancy Fluconazole FDA