Food and Drug Regulations

C.01.051 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.