Actualizaciones regulatorias

Sanofi-Aventis Canada is recalling 1,043 insulin pens and cartridges from ~80 Canadian sites after they may have been frozen during shipping, potentially reducing effectiveness.

Health Canada recalls nine Sarclisa single-use vials from three Nova Scotia locations after possible freezing during shipment.

Health Canada has recalled Ethicon's PERMA-HAND™ Silk Suture after discovering an unapproved alcohol‑based tubing fluid in its primary packaging.

Ethicon recalls PERMA‑HAND™ Silk Suture after discovering an alcohol‑based tubing fluid was used in manufacturing.

Health Canada alerts that the 3930M transvenous DF4 cardiac lead may suffer driveshaft separation due to insufficient adhesive bonding, potentially leading to lead fracture.

Health Canada warns that IMAAVY solution lots JNYJ1202 and JNYJ1206 may contain glass particles; recall limited to healthcare establishments.

Health Canada identified inadequate adhesive coverage in the model 3930M DF4 transvenous lead, which can cause helix separation and potential lead fracture.

Health Canada alerts that counterfeit Soprano laser hair removal machines, made by Beijing Perfectlaser, are being sold to Canadian clinics, posing health risks.

Trinity Biotech is recalling Oxalate Reagent B (Product Code 591-2, Lot 2500711) because of performance variability causing negative bias and under‑recovery of oxalate values, potentially yielding falsely low patient results.

Health Canada has recalled three Organika gummy supplements after discovering they were imported from a foreign manufacturing site not listed on the site licence.

Health Canada now contraindicates TZIELD in patients with active EBV or CMV infection, severe lymphopenia, or who are immunocompromised.

Teva Canada is recalling a lot of Novo‑Gesic Forte 500 mg acetaminophen tablets due to possible phenolic resin or epoxy contamination that could injure the digestive system.