Statement from Sandoz Canada regarding the recall of certain Valsartan product batches.
Jul 16, 2018
Sandoz Canada is recalling batches of Sandoz Valsartan Film-coated tablets at the pharmacist and wholesaler levels. Please note that the recall does not affect Sandoz Valsartan HCT in Canada or any Novartis Pharmaceuticals (Novartis) products containing valsartan, namely Diovan®, Diovan/HCT® and Entresto®. A different API source is used for the above products.
This decision was made in collaboration with Health Canada following the discovery of a substance in the active pharmaceutical ingredient (API). Sandoz is committed to ensuring that all our marketed products meet the highest quality standards and therefore has decided to proceed with the recall in collaboration with Health Canada.
Although this is a Type 1, Level 2 recall via pharmacies and not mandatory from Health Canada to recall Valsartan that is in patients’ hands, it is up to pharmacists to decide if they want to contact their patients or not. It is important that patients do not stop taking their medication without consulting the prescribing physician to ensure continuous treatment of the underlying disease for which the product was prescribed.
Availability of this medicinal product for patients is a top priority for us. Therefore we are exploring possible options with Health Canada to facilitate a continuous supply to cover patient needs.