Safety Alerts & Recalls

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Latest Alerts

Generic Manufacturer Recalls Several Drug Products
Actavis Totowa LLC, a generic drug manufacturer, has voluntarily recalled all drug products manufactured at its Little Falls, New Jersey facility. An FDA inspection at Little Falls revealed operations which did not meet the FDA's or Actavis' standards for good manufacturing practices. This recall includes all MEPERIDINE AND PROMETHAZINE capsules manufactured by Actavis Totowa, LLC. For more information, please visit: http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2008/ucm112477.htm or http://www.actavis.us/RecallFAQ
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FDA Recommends Limits on Use of Erythropoiesis Stimulating Agents in Cancer Patients
The FDA recently ordered changes to the product labeling for the use of erythropoiesis stimulating agents, such as Aranesp, Epogen, or Procrit, in cancer patients. In cancer patients, erythropoiesis stimulating agents are used to treat anemia, a condition where the level of hemoglobin in red blood cells is too low, resulting in stress on bodily organs. The FDA said these drugs should not be used in patients who are expected to be cured of cancer. In addition, the FDA is requiring specific dosing instructions about when to start and stop erythropoiesis stimulating agents in cancer patients. For more information, please visit: http://www.fda.gov/cder/drug/infopage/RHE/default.htm
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Date Published Title Drug Source
2008-08-04 Generic Manufacturer Recalls Several Drug Products Mepergan Manufacturer
2008-08-01 FDA Recommends Limits on Use of Erythropoiesis Stimulating Agents in Cancer Patients FDA
2008-08-01 FDA Recommends Limits on Use of Erythropoiesis Stimulating Agents in Cancer Patients Darbepoetin Alfa FDA
2008-08-01 FDA Recommends Limits on Use of Erythropoiesis Stimulating Agents in Cancer Patients Epoetin Alfa FDA
2008-07-30 Cardiac monitoring recommended Mitoxantrone FDA
2008-07-24 Genetic testing recommended before starting abacavir-containing products Abacavir FDA
2008-07-24 Genetic testing recommended before starting abacavir-containing products Abacavir Sulfate with Lamivudine / Zidovudine FDA
2008-07-24 Genetic testing recommended before starting abacavir-containing products Abacavir with Lamivudine FDA
2008-07-23 Preliminary results from the SEAS trial Ezetimibe with Simvastatin FDA
2008-07-14 Not recommended for combination use Sunitinib Manufacturer
2008-07-14 Not recommended for combination use Bevacizumab Manufacturer
2008-07-08 Increased risk of tendinitis and tendon rupture Levofloxacin FDA
2008-07-08 Increased risk of tendinitis and tendon rupture Moxifloxacin FDA
2008-07-08 Increased risk of tendinitis and tendon rupture Ciprofloxacin FDA
2008-07-08 Increased risk of tendinitis and tendon rupture Ofloxacin FDA
2008-07-03 New Consumer Guide for Patients Warfarin MediGuard CRT
2008-07-03 New Consumer Guide for Patients Alendronate MediGuard CRT
2008-07-03 New Consumer Guide for Patients Ibandronate Sodium MediGuard CRT
2008-07-03 New Consumer Guide for Patients Risedronic Acid MediGuard CRT
2008-07-03 New Consumer Guide for Patients Teriparatide MediGuard CRT