In November 2026, the CHMP, in alignment with CMDh, agreed on an updated version of the question-and-answers document for marketing authorisation holders and applicants on implementing the Article 5(3) CHMP opinion on Nitrosamines impurities.

Recall due to a defective finger grip on the pre-filled syringe

Recall due to unregistered serial numbers

Recall due to visible particles

Recall due to possible contamination with particles

Recall due to out of specification results for dissolution

Recall due to deviations from quality standards at the production site

Recall due to incorrect labelling

Recall due to possible contamination with particles

Recall due to a crimping defect