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FDA Alerts

safety alerts

Alerts

  • Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall

    Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India. The impurity found in Mylan’s […]Read More »
  • Class 2 Device Recall AMIA Automated PD Cycler

    Class 2 Device Recall AMIA Automated PD Cycler Tuesday, August 21, 2018 Baxter Healthcare Corporation has issued a recall for the following power cords: AMIA Automated PD Cycler, Product Code: 5C9320 Kaguya PD System, Product Code: T5C8500 Read MoreRead More »
  • Hospira Issues Voluntary Nationwide Recall

    Hospira, Inc., a Pfizer company, is voluntarily recalling 8 lots of Hospira’s Daptomycin for Injection 500 mg, Lyophilized Powder For Solution, Single Dose Vial (NDC 0409-0106-01) to the Hospital/Retail level. The product is being recalled due to adverse event reports indicative of infusion reactions. Daptomycin for Injection has been associated with reports of adverse events indicative of […]Read More »
  • HeartMate 3™ Left Ventricular Assist System: Class I Recall

    HeartMate 3™ Left Ventricular Assist System: Class I Recall – Due to Potential Malfunction that may Lead to Graft Occlusion The class I recall is due to a malfunction in the device’s outflow graft assembly that may cause the outflow graft to twist and close up (occlusion) over time. Occlusion of the outflow graft can […]Read More »
  • Class 2 Device Recall 2008 Series Hemodialysis Machine

    Class 2 Device Recall 2008 Series Hemodialysis Machine Fresenius Medical Care Renal Therapies is recalling its dialyzer, high permeability with or without sealed dialysate system, 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number) […]Read More »