Safety Alerts & Recalls

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Recall on All ETHEX Brand Hyoscyamine
The ETHEX Corporation, a subsidiary of KV Pharmaceutical, has recalled ALL lots of ETHEX brand hyoscyamine tablets and capsules. These recalled tablets and capsules 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 capsules 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. Hyoscyamine Orally Disintegrating Tablets, 0.125mg (NDC 58177-423-04) Hyoscyamine Sublingual Tablets, 0.125mg (NDC 58177-255-04) Hyoscyamine Sulfate Oral Tablets, 0.125mg (NDC 58177-274-04) Hyoscyamine Sulfate ER Tablets, 0.375mg (NDC 58177-237-04) Hyoscyamine Sulfate ER Capsules, 0.375mg (NDC 58177-017-04) For more information, please visit: http://www.ethex.com/news/pressRelease012809.aspx
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Recall on All ETHEX Brand Isosorbide Mononitrate ER Tablets
The ETHEX Corporation, a subsidiary of KV Pharmaceutical, has recalled ALL lots of ETHEX brand isosorbide mononitrate extended release 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. Isosorbide Mononitrate ER Tablets, 30mg (NDC 58177-222-04, NDC 58177-222-08 & NDC 58177-222-11) Isosorbide Mononitrate ER Tablets, 60mg (NDC 58177-238-04, NDC 58177-238-08 & NDC 58177-238-11) Isosorbide Mononitrate ER Tablets, 120mg (NDC 58177-201-04) 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 All ETHEX Brand Hyoscyamine Hyoscyamine Manufacturer
2009-01-29 Recall on All ETHEX Brand Isosorbide Mononitrate ER Tablets Isosorbide Manufacturer
2009-01-29 Recall on All ETHEX Brand Morphine Tablets and Solution Morphine Manufacturer
2009-01-29 Recall on All ETHEX Brand NitroQuick Sublingual Tablets Nitroglycerin Manufacturer
2009-01-29 Recall on All ETHEX Brand Ondansetron Tablets Ondansetron Manufacturer
2009-01-29 Recall on All ETHEX Brand Oxycodone Tablets and Capsules Oxycodone Manufacturer
2009-01-29 Recall on All ETHEX Brand Propafenone Tablets Propafenone Manufacturer
2009-01-29 Recall on All ETHEX Brand Hydromorphone Tablets Dilaudid FDA
2009-01-29 Recall on All ETHEX Brand Metoprolol Succinate Extended Release Tablets Metoprolol Manufacturer
2009-01-29 Recall on All ETHEX Brand Potassium Chloride Capsules and Tablets Potassium Manufacturer
2009-01-29 Recall on All ETHEX Brand Nystatin Topical Powder Nystatin Manufacturer
2009-01-29 Recall on All ETHEX Brand Guaifenex PSE and Pseudovent Guaifenesin / Pseudoephedrine Manufacturer
2009-01-29 Recall on All ETHEX Brand Prednisolone Oral Solution and Syrup Prednisolone Manufacturer
2009-01-29 Recall on Ther-Rx Brand Gynazole-1 Manufacturer
2009-01-29 Recall on Ther-Rx Brand Clindesse Clindamycin Manufacturer
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