Safety Alerts & Recalls

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Latest Alerts

Recall on Ther-Rx Brand Potassium Supplements
The Ther-Rx Corporation, a subsidiary of KV Pharmaceutical, has recalled all lots of Ther-Rx brand microK Extencaps which contain the active ingredient potassium chloride. These recalled capsules may have been manufactured under conditions that did not meet the current manufacturing standards called Good Manufacturing Practices (cGMPs). Ther-Rx is now recalling all of their products to ensure that these products do not reach patients. The Ther-Rx capsules and the NDC numbers involved in the recall are listed below. The NDC number is a product number that is sometimes listed on a prescription label. microK Extencaps 8mEq, (NDC 64011-0010-04, NDC 64011-0010-11, & NDC 64011-0010-08) microK Extencaps 10mEq, (NDC 64011-0009-04, NDC 64011-0009-11, & NDC 64011-0009-08) For more information, please visit: http://www.ther-rx.com/pressRelease012809.aspx
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Recall on All ETHEX Brand Amlodipine Tablets
The ETHEX Corporation, a subsidiary of KV Pharmaceutical, has recalled ALL lots of amlodipine besylate 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. Amlodipine Besylate Tablets, 2.5mg (NDC 58177-536-26) Amlodipine Besylate Tablets, 5mg (NDC 58177-537-26, NDC 58177-537-537-07, & NDC 58177-537-537-11) Amlodipine Besylate Tablets, 10mg (NDC 58177-538-26 & NDC 58177-538-11) For more information, please visit: http://www.ethex.com/news/pressRelease012809.aspx
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Date Published Title Drug Source
2009-01-29 Recall on Ther-Rx Brand Potassium Supplements Potassium Manufacturer
2009-01-28 Recall on All ETHEX Brand Amlodipine Tablets Amlodipine Manufacturer
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
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