Safety Alerts & Recalls

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New Safety Information for Fosphenytoin
FDA is investigating a potential increased risk of serious skin reactions from FOSPHENYTOIN (CEREBYX) in Asian patients who have tested positive for a specific gene. These serious skin reactions include Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) which often begin with several days of flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters. FOSPHENYTOIN is used to control seizures. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110259.htm
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Recall of Several Lots of Bidex-DMI Cold Medicine with Guaifenesin and Dextromethorphan
Pharmakon Labs, Inc has voluntarily recalled several lots of Bidex-DMI, a cold medicine that contains guaifenesin and dextromethorphan. The lot numbers involved in the recall were packaged in bottles that contained 100 tablets and also as physician sample boxes. This recall notice applies to these lot numbers: lot 7K08 with expiration September 2009 and lots 7K10, 7M10, and 8B06 with expiration March 2009. These lot numbers of Bidex-DMI are being recalled because some of the tablets were not labeled correctly. For more information, please visit: http://www.fda.gov/Safety/Recalls/EnforcementReports/2007/ucm120479.htm
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Date Published Title Drug Source
2008-11-25 New Safety Information for Fosphenytoin Fosphenytoin FDA
2008-11-25 Recall of Several Lots of Bidex-DMI Cold Medicine with Guaifenesin and Dextromethorphan Guaifenesin with Dextromethorphan FDA
2008-11-25 Recall of Several Lots Zaditor Eye Drops Ketotifen FDA
2008-11-25 Recall of Fenofibrate (Fenoglide) Physician Samples Fenofibrate FDA
2008-11-18 Recall of Several Lots of Perphenazine Perphenazine FDA
2008-11-14 Update on FDA Safety Review of Bisphosphonates Alendronate and Vitamin D FDA
2008-11-14 Update on FDA Safety Review of Bisphosphonates Etidronic Acid FDA
2008-11-14 Update on FDA Safety Review of Bisphosphonates Ibandronate Sodium FDA
2008-11-14 Update on FDA Safety Review of Bisphosphonates Pamidronate Disodium FDA
2008-11-14 Update on FDA Safety Review of Bisphosphonates Risedronic Acid FDA
2008-11-14 Update on FDA Safety Review of Bisphosphonates Actonel Plus Calcium FDA
2008-11-14 Update on FDA Safety Review of Bisphosphonates Tiludronic Acid FDA
2008-11-14 Update on FDA Safety Review of Bisphosphonates Zoledronic Acid FDA
2008-11-14 Voluntary Recall of Topical Acne Cream Benzoyl Peroxide FDA
2008-11-14 Recall of Additional Lot of PREMPRO 0.3 mg/1.5 mg EZ-DIAL Dispensers Estrogens Conjugated with Medroxyprogesterone FDA
2008-11-13 Early Communication about Potential Drug Interaction Between PLAVIX and PROTON PUMP INHIBITORS Clopidogrel MediGuard CRT
2008-11-13 Early Communication about Potential Drug Interaction Between PLAVIX and PROTON PUMP INHIBITORS Esomeprazole MediGuard CRT
2008-11-13 Early Communication about Potential Drug Interaction Between PLAVIX and PROTON PUMP INHIBITORS Lansoprazole MediGuard CRT
2008-11-13 Early Communication about Potential Drug Interaction Between PLAVIX and PROTON PUMP INHIBITORS Omeprazole MediGuard CRT
2008-11-13 Early Communication about Potential Drug Interaction Between PLAVIX and PROTON PUMP INHIBITORS Pantoprazole MediGuard CRT
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