Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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원인
After investigation of the returned product it was confirmed that particulate may be generated when the tip of the needle pushes through the rubber septum of the vial. this presents a potential safety risk of a particulate being injected into a patient and while remote a potential risk of significant harm exists.