Orion withdraws all Devisol Salmiakki from market

Pharmaceutical company Orion is recalling all Devisol Salmiakki dietary supplement packages from consumers due to excessive levels of matrine in the product, said the company in a press release on Monday.

Devisol Salmiakki has been on sale in Finland only starting from December 2021.

Consumers are requested to return both opened and unopened Devisol Salmiakki products to the nearest pharmacy at the latest on 13 October.

The products will be reimbursed for the consumers. Empty packages or free samples will not be reimbursed. The recall does not concern Orion's other Devisol products.

The recall is due to levels of matrine in the licorice extract used in the Devisol Salmiakki product which have been found to exceed the maximum level allowed by the EU.

Matrine occurs naturally in certain plants and is also used as a pesticide. Regarding matrine, there is no EU-level risk assessment and approval, and there is therefore no certainty about the safety of foodstuffs containing it.

As a precaution, all batches of Devisol Salmiakki on the market are withdrawn.

The daily recommended dose of Devisol Salmiakki is one tablet, in which case the exposure to matrine through this preparation is assumed to be low.

Orion has not received any reports of adverse effects related to the Devisol Salmiakki product, and Orion is not aware of any consumer reports related to the safety of the Devisol Salmiakki product.

The recall has no material financial impact on Orion.

Orion apologises for the inconvenience that returning the product causes for its customers.