Health Canada Recalls Apo-Semaglutide Lot 7000636A Over Incorrect Dose Display

Health Canada has posted a Type II recall for one lot of Apo-Semaglutide injection after a device issue was identified in the 4 mg pen. An affected pen may display 0.25 mg or 0.5 mg in the dose window and deliver that amount instead of the expected 1 mg dose.

Recall details

The defect can result in delivery of less semaglutide than the intended 1 mg dose. Pharmacies in the affected provinces should identify and quarantine lot 7000636A, reconcile dispensing records and follow Apotex recall instructions.

Health Canada advises patients to verify their product and consult a healthcare provider before discontinuing treatment or if they have concerns. Patients should not change the dose or attempt to compensate for a suspected underdose without professional advice.

Practice guidance for pharmacists

• Quarantine Apo-Semaglutide lot 7000636A and reconcile on-hand inventory, transfers and recent dispensing records.
• Verify the DIN and lot on every 4 mg Apo-Semaglutide pen in stock; keep unaffected inventory clearly separated.
• Use patient profiles to identify recipients of the recalled lot and follow the manufacturer’s instructions for notification, return and replacement.
• Advise patients not to stop, change or repeat a dose without an individualized plan from their pharmacist or prescriber.
• Document all follow-up and report unexpected dose-window behaviour, product-quality complaints and suspected adverse reactions to Health Canada.