Advisory - One lot of Verkazia (cyclosporine) eye drops recalled due to potential presence of particulate matter

OTTAWA, ON, Nov. 12, 2021 /CNW/ -

Summary

Verkazia box (CNW Group/Health Canada)

• Product: Verkazia (cyclosporine) eye drops (DIN 02484137, lot 1N81H)
• Issue: McKesson Specialized Distribution is recalling one lot of Verkazia (cyclosporine) eye drops due to the potential presence of particulate matter, which may irritate the eyes and reduce the effectiveness of treatment.
• What to do: If you see particulate matter (e.g. crystal-like particles) in the vials or if your eye symptoms worsen, stop using the product and consult your pharmacist to obtain a replacement as soon as possible. Consult a health care professional if you have used this product and have health concerns.  

Issue
McKesson Specialized Distribution (MSD) is recalling one lot (1N81H) of Verkazia (cyclosporine) eye drops after certain vials from the lot were found to contain particulate matter. The manufacturer, Santen Inc., determined the particles were a crystalized form of the active drug ingredient, cyclosporine. The particulate matter may irritate the surface of the eye. Solidified cyclosporine may also reduce the concentration of the drug in the solution, which may reduce the treatment's effectiveness.

MSD, the Canadian importer, also recalled one lot (1N80H) of Verkazia in August 2021 due to the potential presence of particulate matter, which was identified during routine testing. Santen Inc. continues to investigate the cause of this issue and will report its findings to Health Canada.

Verkazia is a prescription drug used in children and adolescents from 4 to 18 years of age to treat a severe form of eye allergy called "vernal keratoconjunctivitis."

Health Canada is monitoring MSD's recall. If additional safety information is identified, Health Canada will take appropriate action and inform Canadians as needed. 

Affected products

Product	Manufacturer / Canadian Importer	DIN	Lot	Expiry
Verkazia (cyclosporine) eye drops	Santen Inc. / McKesson Specialized Distribution	02484137	1N81H	02/2023

What you should do

• If you see particulate matter (e.g. crystal-like particles) in the vials or if your eye symptoms worsen, stop using the product and consult your pharmacist to obtain a replacement as soon as possible.
• Consult a health care professional if you have taken a recalled product and have health concerns.
• Contact McKesson Specialized Distribution by calling 1-877-827-1306 or emailing [email protected] if you have questions about the recall.
• Report any health product-related side effects or complaints to Health Canada.

Également disponible en français  

SOURCE Health Canada

Media Enquiries: Également disponible en français, Health Canada, [phone], [email protected]; Public Enquiries: [phone], 1-866 225-0709, [email protected]