Safety Alerts & Recalls

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Latest Alerts

Recall on All ETHEX Brand Benazepril Tablets
The ETHEX Corporation, a subsidiary of KV Pharmaceutical, has recalled ALL lots of benazepril HCl tablets. These recalled tablets may have been manufactured under conditions that did not meet the current manufacturing standards called Good Manufacturing Practices (cGMPs). Some ETHEX products have recently had specific lots recalled due to defects found, including oversized tablets. ETHEX is now recalling all of their products to ensure that no other defective products remain available to patients. The ETHEX tablets and their NDC numbers involved in the recall are listed below. The NDC number is a product number that is sometimes listed on a prescription label. Benazepril HCl Tablets, 5mg (NDC 58177-341-04) Benazepril HCl Tablets, 10mg (NDC 58177-342-04 & NDC 58177-342-08) Benazepril HCl Tablets, 20mg (NDC 58177-343-04 & NDC 58177-343-08) Benazepril HCl Tablets, 40mg, (NDC 58177-344-04 & NDC 58177-344-08) For more information, please visit: http://www.ethex.com/news/pressRelease012809.aspx
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FDA Early Communication About an Ongoing Safety Review
The FDA announced that it is working with the makers of Plavix to study how genetic factors and other drugs (especially the proton pump inhibitors (PPIs)) may alter the effectiveness of clopidogrel, the active ingredient in Plavix. This FDA action was prompted by recent reports suggesting clopidogrel does not work as well in some patients as it does in others. Differences in effectiveness may be due to changes in the way the body breaks down clopidogrel. iGuard discussed one of these studies in a previous alert issued in November 2008 related to use of Plavix and proton pump inhibitors (Aciphex, Nexium, Prevacid, Prilosec, or Protonix). The FDA recognizes the importance of investigating these issues in a timely manner. However, it could take several months to complete the studies and analyze the results. For more information please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm079520.htm To read the November 2008 alert about this issue, please visit: http://iguard.org/alert.html?aid=334
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Date Published Title Drug Source
2009-01-28 Recall on All ETHEX Brand Benazepril Tablets Benazepril Manufacturer
2009-01-27 FDA Early Communication About an Ongoing Safety Review Clopidogrel FDA
2009-01-23 Safety Alert on Incorrect Use of Skin Numbing Products Lidocaine FDA
2009-01-23 Safety Alert on Incorrect Use of Skin Numbing Products Benzocaine FDA
2009-01-23 Safety Alert on Incorrect Use of Skin Numbing Products Prilocaine FDA
2009-01-23 Safety Alert on Incorrect Use of Skin Numbing Products Tetracaine FDA
2009-01-20 Lorabid No Longer Available in the United States FDA
2009-01-16 Recall of Single Lot of MHL Labeled Ibuprofen 200 mg Tablets Ibuprofen FDA
2009-01-16 Recall on Selected Metoprolol Extended Release Products Metoprolol FDA
2009-01-15 Newer Antipsychotics Linked to Heart Risks Clozapine MediGuard CRT
2009-01-15 Newer Antipsychotics Linked to Heart Risks Quetiapine MediGuard CRT
2009-01-15 Newer Antipsychotics Linked to Heart Risks Olanzapine MediGuard CRT
2009-01-15 Newer Antipsychotics Linked to Heart Risks Risperidone MediGuard CRT
2009-01-15 Antipsychotics Linked to Heart Risks Haloperidol MediGuard CRT
2009-01-15 Antipsychotics Linked to Heart Risks Thioridazine MediGuard CRT
2009-01-14 Update on FDA Safety Review Zileuton FDA
2009-01-14 Update on FDA Safety Review Zafirlukast FDA
2009-01-14 Update on FDA Safety Review Montelukast FDA
2009-01-12 New Antidepressant Guide for Patients Bupropion FDA
2009-01-12 New Antidepressant Guide for Patients Citalopram FDA