We have written procedures in place that specify responsibilities and necessary actions in the unlikely event of a product recall situation. Our policies clearly define who should be involved in evaluating the information, how a recall should be initiated and who should be informed.

As part of our recall policy, we address the following, together with our marketing partners.

• The depth of recall – defined by the material’s degree of hazard and the extent of distribution
• Whether a public warning is necessary, based on the potential health risks
• Informing local, national and/or international authorities, and seeking their advice if the situation is potentially serious or life-threatening
• How often recall effectiveness checks should be performed and to what level.

When our API has already been converted into a final dosage form and distributed, the recall and safe disposal of the material is carried out in close cooperation with the relevant customer, wholesaler or distributor.