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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The certificate of analysis (coa) and the primary labels of the affected vials of m3636 were mislabeled with an incorrect protein concentration value of 292.7 mg/l which is sixteen times higher than the correct concentration of 18.3 mg/l.
Model Catalog: M3636 (Lot serial: M363629-2 lot 10117138); Model Catalog: M3636 (Lot serial: M363601-2 lot 10121392); Model Catalog: M3636 (Lot serial: M363629-2 lot 10121395); Model Catalog: M3636 (Lot serial: M363601-2 lot 10117361)