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Bone Graft Substitutes Containing Recombinant Proteins or Synthetic Peptides in Patients Under Age 18: FDA Safety Communication
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Simulated IV Solutions from Wallcur: CDER Statement- FDA’s Investigation into Patients being Injected
[Posted 1/14/2015] AUDIENCE: Risk Manager, Health Professionals, Pharmacy ISSUE: FDA and the Centers for Disease Control and Prevention (CDC) are continuing to investigate multiple instances of Wallcur’s simulated intravenous (IV) saline products being administered to patients. These products are not sterile and should not be injected in humans or animals. So far, more than 40…
Prescription and Over-the-Counter (OTC) Pain Medicines: Drug Safety Communication
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Virazole (Ribavirin Powder For Solution) by Valeant Pharmaceutical North America, LLC: Recall- Due to Microbial Contamination
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KimVent Microcuff Subglottic Suctioning Endotracheal Tubes by Halyard Health: Class I Recall
[Posted 12/31/2014] AUDIENCE: Critical Care Medicine, Risk Manager, Emergency Medicine ISSUE: The cuff inflation line of certain KimVent Microcuff Endotracheal tubes may detach from the tube during use (if pulled, tugged, or excess tube/patient movement occurs). If the inflation line detaches, the cuff will gradually deflate. This may lead to an air leak between the…
Nellcor Puritan Bennett 980 Ventilator System by Covidien: Class I Recall
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IV Solutions from Wallcur of San Diego: CDER Statement
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Caramel Apples: Warning
[Posted 12/25/2014] AUDIENCE: Emergency Medicine, Primary Care, Consumer ISSUE: FDA is notifying healthcare professionals and their medical care organizations of the ongoing investigation of an outbreak of listeriosis linked to commercially-produced, prepackaged caramel apples. The CDC reports that 29 people in 10 states have been reported as being infected with the outbreak strains of Listeria monocytogenes,…
Mitoxantrone by Hospira: Recall – Confirmed Subpotency and Out-Of
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