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FDA, EMA, TGA and global regulatory developments

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UPDATED
Regulatory Updates
Sep 27, 2026•1 min read
Sanofi-Aventis Canada Recalls Certain Insulin Pens and Cartridges Over Freezing Risk
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.
UPDATED
Regulatory Updates
Sep 25, 2026•1 min read
Limited Number of Sarclisa Single-Use Vials Recalled in Nova Scotia Due to Possible Freezing
Health Canada recalls nine Sarclisa single-use vials from three Nova Scotia locations after possible freezing during shipment.
UPDATED
Regulatory Updates
Sep 25, 2026•1 min read
Canada Recalls PERMA-HAND Silk Suture for Unapproved Tubing Fluid
Health Canada has recalled Ethicon's PERMA-HAND™ Silk Suture after discovering an unapproved alcohol‑based tubing fluid in its primary packaging.
UPDATED
Regulatory Updates
Sep 25, 2026•1 min read
Health Canada Recall: PERMA‑HAND™ Silk Suture Contaminated with Alcohol‑Based Tubing Fluid
Ethicon recalls PERMA‑HAND™ Silk Suture after discovering an alcohol‑based tubing fluid was used in manufacturing.
UPDATED
Regulatory Updates
Sep 23, 2026•1 min read
Health Canada Issues Alert on 3930M Transvenous DF4 Cardiac Lead Adhesive Issue
Health Canada alerts that the 3930M transvenous DF4 cardiac lead may suffer driveshaft separation due to insufficient adhesive bonding, potentially leading to lead fracture.
UPDATED
Regulatory Updates
Sep 23, 2026•1 min read
Health Canada Alert: IMAAVY Lots May Contain Glass Particles
Health Canada warns that IMAAVY solution lots JNYJ1202 and JNYJ1206 may contain glass particles; recall limited to healthcare establishments.
UPDATED
Regulatory Updates
Sep 23, 2026•1 min read
Health Canada alerts on model 3930M transvenous DF4 lead adhesive bond issue
Health Canada identified inadequate adhesive coverage in the model 3930M DF4 transvenous lead, which can cause helix separation and potential lead fracture.
UPDATED
Regulatory Updates
Sep 18, 2026•1 min read
Health Canada Warns of Counterfeit Soprano Laser Hair Removal Devices
Health Canada alerts that counterfeit Soprano laser hair removal machines, made by Beijing Perfectlaser, are being sold to Canadian clinics, posing health risks.
UPDATED
Regulatory Updates
Sep 17, 2026•1 min read
Trinity Biotech Recalls Oxalate Reagent B (Lot 2500711) Due to Performance Variability
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.
UPDATED
Regulatory Updates
Sep 15, 2026•1 min read
Health Canada Issues Recall for Organika Lion's Mane, Reishi and Creatine Gummies
Health Canada has recalled three Organika gummy supplements after discovering they were imported from a foreign manufacturing site not listed on the site licence.
UPDATED
Regulatory Updates
Sep 14, 2026•2 min read
Health Canada adds viral reactivation warning to TZIELD product monograph
Health Canada now contraindicates TZIELD in patients with active EBV or CMV infection, severe lymphopenia, or who are immunocompromised.
UPDATED
Regulatory Updates
Sep 10, 2026•1 min read
Teva Canada Recalls Novo‑Gesic Forte 500 mg Acetaminophen Over Potential Foreign Material
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.