Health Canada Recalls Cyclophosphamide Injection Lot Over Possible Particulate Matter

Health Canada has posted a national Type I recall for one lot of Marcan Pharmaceuticals’ Cyclophosphamide for Injection USP after particulate matter was identified. The recall applies to healthcare establishments and is limited to a single 1,000 mg/vial presentation and lot. Because cyclophosphamide is a hazardous antineoplastic medicine used in specialist and hospital care, the notice warrants prompt, lot-specific checking by pharmacy teams that handle the product.

What is affected

• Product: Cyclophosphamide for Injection USP, powder for solution
• Manufacturer: Marcan Pharmaceuticals Inc.
• DIN: 02560216
• Strength: 1,000 mg per vial
• Affected lot: 7Z10346A
• Distribution: National; depth of recall is healthcare establishments

Health Canada classifies the action as a Type I recall. The agency’s alert identifies the quality issue as particulate matter in the affected lot. It does not describe the particles, report a patient outcome, or say that other lots or strengths are affected. Pharmacies should therefore avoid extending the notice beyond the exact product and lot identified unless Marcan or a regulator issues further direction.

What hospital and oncology pharmacy teams can do

Start with a targeted inventory check. Search the primary pharmacy, oncology preparation areas, satellite locations, automated cabinets and any other storage locations where the affected product may be held. Compare the manufacturer and DIN as well as the lot number; a product-name match alone is not enough. If the lot is present, segregate it from usable stock and follow the recall firm’s instructions for disposition, return or replacement. Keep a record of the quantity located and the action taken under the organization’s recall procedure.

If the lot has already been dispensed or used, follow the institution’s established traceability and escalation process. The organization’s oncology, medication-safety and clinical teams can determine whether administration records need to be reviewed and who should be contacted. Health Canada’s notice advises people with health concerns to consult a healthcare provider; it directs questions about the recall to the recalling firm and provides channels for reporting suspected side effects or other safety complaints. The alert itself does not provide a patient-specific clinical management protocol.

Why the lot number matters

Recall alerts are often narrow because manufacturing and distribution records can identify a specific batch. A careful, documented check helps remove the affected stock without creating unnecessary disruption to treatment or mistakenly withdrawing unaffected inventory. For a sterile injectable used in cancer care, even a quality concern that has not been linked to a reported injury deserves a clear handoff between procurement, pharmacy operations and the clinical service.

Community pharmacies that do not routinely stock this hospital-use product may still receive questions from patients or caregivers. A useful response is to verify the exact product and lot against the official notice, avoid speculating about individual risk, and direct clinical questions to the treating team or manufacturer’s recall contact. Any suspected product-related reaction or quality complaint can be reported through Health Canada’s established channels.

What to watch next

Pharmacy teams should monitor the official recall page and communications from Marcan or their distributor for any change in scope or additional handling details. The notice identifies the recall as national and gives the affected lot, DIN and recall classification; those specifics should guide the initial response.

Practice note: The inventory and traceability steps above are operational considerations for pharmacy teams, not additional directions issued by Health Canada. Follow your organization’s recall policy and the manufacturer’s instructions.