Evrysdi (roche)
Roche is recalling Evrysdi powder for oral solution (0.75 mg/mL) in New Zealand due to a product alert. This recall is classified as Class I, meaning there is a serious potential health risk. The recall affects healthcare professionals and facilities in New Zealand that have received this product.
- Recalling firm
- Roche Products (NZ) Ltd
- Product
- Evrysdi (Roche). [Medicine]. Form: Powder for oral solution 0.75 mg/mL
- Reason
- Multiple complaints from a pharmacy in Germany identified visible insoluble particles after reconstitution of Evrysdi® 0.75 mg/mL powder for oral solution. Particles were confirmed primarily as PTFE (Teflon), with sizes ~0.3-2.7 mm; minor quantities of PP/PE/PA/cellulose fibres also detected., Roche is proposing a DHCP letter and continue to supply the product.
- Classification
- Class I
- Category
- drug recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-05-15
- Status
- Ongoing
- Distribution
- New Zealand - Healthcare Professional
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/ced84794-35dd-4269-bf05-d27317f11097