Category Archives: FDA Recall

Soliris (Eculizumab) Concentrated Solution Alexion Recall

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Soliris (Eculizumab) Concentrated Solution for Intravenous Infusion by Alexion: Recall – Visible Particles AUDIENCE: Hematology, Pharmacy ISSUE: Alexion Pharmaceuticals, Inc. is providing information regarding a previously communicated voluntary recall of two lots of Soliris (eculizumab) Concentrated Solution for Intravenous Infusion. … Continue reading

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FreeStyle and FreeStyle Lite Blood Glucose Test Strips by Abbott Recall

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FreeStyle and FreeStyle Lite Blood Glucose Test Strips by Abbott: Recall – Erroneously Low Blood Glucose Results AUDIENCE: Consumer, Family Physician, Pharmacy ISSUE: Abbott is initiating a voluntary recall of 20 lots of FreeStyle and FreeStyle Lite Blood Glucose Test … Continue reading

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Nitroglycerin in 5% Dextrose Injection by Baxter Recall

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Nitroglycerin in 5% Dextrose Injection by Baxter: Recall – Particulate Matter AUDIENCE: Risk Managers, Critical Care Medicine, Cardiology ISSUE: Baxter International Inc has initiated a voluntary recall of one lot of Nitroglycerin in 5% Dextrose Injection due to particulate matter … Continue reading

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Spacelabs Anesthesia Workstations and Service Kits Class I Recall

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Spacelabs Healthcare, Inc., Spacelabs Anesthesia Workstations and Service Kits: Class I Recall – Bag-to-Vent Switch in CAS I/II Absorbers May Fail AUDIENCE: Risk Manager, Anesthesiology ISSUE: FDA notified healthcare professionals of a Class I Recall due to a potential defect in … Continue reading

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CLR Medicals International Inc Viscoelastic Products Recall

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CLR Medicals International Inc. Viscoelastic Products: Recall – Quality System Deficiencies And Lack Of Premarket Approval (PMR) AUDIENCE: Risk Management, Health Professional ISSUE: CLR Medicals International Inc., initiated a nationwide recall of Viscocel and Viscocel Plus, in response to FDA … Continue reading

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Hospira GemStar Infusion System Class I Recall

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Hospira GemStar Infusion System: Class I Recall – Pressure Sensor Calibration Drift AUDIENCE:  Biomedical Engineering, Nursing, Critical Care Medicine, Home Care, Risk Manager ISSUE: The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal … Continue reading

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Nature’s Pharmacy and Compounding Center Sterile Compounded Products Recall

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Nature’s Pharmacy and Compounding Center Sterile Compounded Products: Recall – Lack of Sterility Assurance AUDIENCE: Health Professional ISSUE: Nature’s Pharmacy and Compounding Center of Asheville, NC is voluntarily recalling all lots of sterile products compounded by the pharmacy that are … Continue reading

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Medtronic Guidewires Recall

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Medtronic Guidewires: Recall – Potential For Coating On Surface To Delaminate And Detach AUDIENCE: Health Professional, Cardiology, Risk Management ISSUE: Medtronic, Inc.announced that FDA has classified the company’s recently initiated voluntary field action related to certain guidewire. Based on an internal … Continue reading

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OxyElite Pro Dietary Supplements by USP Labs Recall

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OxyElite Pro Dietary Supplements by USP Labs: Recall – Products Linked to Liver Illnesses AUDIENCE: Consumers, Healthcare Professionals ISSUE: The U.S. Food and Drug Administration announced today that USPlabs LLC, of Dallas, Texas, is recalling certain OxyElite Pro dietary supplement … Continue reading

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Baylis Medical TorFlex Transseptal Guiding Sheath Kit Class I Recall

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Baylis Medical TorFlex Transseptal Guiding Sheath Kit: Class I Recall – Sheath Could Remove Particulate AUDIENCE: Cardiology, Risk Manager ISSUE:  FDA notified healthcare professionals of the Class 1 recall of TorFlex Transseptal Guiding Sheath Kit.  The sheath could remove particulate … Continue reading

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