Clozapine blood monitoring revised; insulin and Sarclisa recalls
- 28-09-2026
- Posted by: Eldaniz Hasanov
- Category: Regulatory Updates
Swissmedic revised recommendations for clozapine medicines because of the risk of neutropenia and agranulocytosis. Monitoring should use the absolute neutrophil count (ANC); treatment thresholds, monitoring intervals and conditions for rechallenge after mild neutropenia were updated.
Health Canada announced a recall of specific Sanofi insulin pens and cartridges that may have frozen during shipping. Reduced insulin effectiveness may cause severe hyperglycaemia. Nine Sarclisa 500 mg/25 mL vials from lot 5F028A were also recalled because they may have frozen in transit. Only identified units, not the entire lots, are affected.
Sources: Swissmedic, Health Canada — insulins, Health Canada — Sarclisa.
Disclaimer. This material is provided solely for information and pharmacovigilance purposes, based on the official Swissmedic communication dated 26 September 2026 and Health Canada communications dated 25 September 2026. It is not medical or legal advice, does not replace the official sources, and does not imply wrongdoing by the manufacturer/marketing authorisation holder or a quality concern affecting the company’s entire product portfolio. Company and product names are used only to identify the official materials accurately. Decisions should be based on the primary sources, the regulators’ instructions and the approved product information.