FDA analysis of Wallcur’s simulated Practi-0.9% sodium chloride IV is now complete

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FDA report “FDA’s laboratory analysis of Wallcur’s simulated Practi-0.9% sodium chloride IV is now complete. FDA sampled 11 of Wallcur’s simulated saline solution bags and identified large amounts of endotoxin and significant bacterial contamination in the samples. These include bacteria (e.g., Bacillus spp., Brevundimonas sp., Pseudomonas spp., Rhizobium radiobacter, Sphingomonas koreensis, Sphingomonas trueperi, Sphingobium sp.). It is possible that additional bacteria are present in other bags that were not included in this analysis.

FDA is aware of more than 40 individuals who received infusions of the simulated Practi-0.9% sodium chloride IV products; 26 of whom reported adverse events that ranged from flu-like symptoms to sepsis, a potentially life-threatening complication of an infection. Of those 26 individuals, 2 deaths and 11 hospitalizations were reported”

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