Government of Canada / Gouvernement du Canada
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Food and Drug Regulations

Version of section C.01.051 from 2006-03-22 to 2018-04-03:

 Where a manufacturer who sells a drug in dosage form or a person who imports into and sells in Canada a drug in dosage form commences a recall of the drug, the manufacturer or importer shall forthwith submit to the Director the following information:

  • (a) the proper name of the drug, the common name of the drug if there is no proper name, the brand name of the drug and the lot number;

  • (b) in the case of an imported drug, the names of the manufacturer and importer;

  • (c) the quantity of the drug manufactured or imported;

  • (d) the quantity of the drug distributed;

  • (e) the quantity of the drug remaining on the premises of the manufacturer or importer;

  • (f) the reasons for initiating the recall; and

  • (g) a description of any other action taken by the manufacturer or importer with respect to the recall.

  • SOR/82-524, s. 2
  • SOR/93-202, s. 11

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