ANTICOAGULANT SODIUM CITRATE SOLUTION, USP 4g/100mL and Potential Bag Leaks

Issue

Certain lots (see Appendix 1) of Fresenius Kabi Canada Ltd’s ANTICOAGULANT SODIUM CITRATE SOLUTION, USP 4g/100mL have the potential to leak because of manufacturing-related defects. A leaking bag may result in a loss of anticoagulant solution, an interruption of the apheresis procedure, or microbial contamination of the solution. Audience Healthcare professionals including physicians, nurses, pharmacists, and other medical and support personnel, including inventory management, involved in the administration and handling of Fresenius Kabi Canada Ltd’s ANTICOAGULANT SODIUM CITRATE SOLUTION, USP 4g/100mL, as well as any consignees that may have received the product through your organization. Key messages Certain lots of Fresenius Kabi Canada Ltd’s ANTICOAGULANT SODIUM CITRATE SOLUTION, USP 4g/100mL have the potential to leak because of manufacturing-related defects. A leaking bag may result in a loss of anticoagulant solution, an interruption of the apheresis procedure, or microbial contamination of the solution. Healthcare professionals are advised of the following: Regardless of the lot, inspect each bag prior to use by removing the overwrap and squeezing the inner bag firmly to check for small leaks, as directed on the product label. Discard the bag if it is observed to be leaking or damaged, or if the solution is not clear, because sterility may be impaired. Report any observed leaks, bag damage, or other product quality concerns to Fresenius Kabi Canada Ltd. Ensure that all relevant personnel in your organization are informed of this communication, including any consignees that may have received the product through your organization. Background Information ANTICOAGULANT SODIUM CITRATE SOLUTION, USP 4g/100mL is a sterile, non-pyrogenic, single-use solution containing sodium citrate as an active ingredient and is to be used with apheresis devices only. It is not intended for direct intravenous infusion into patients. Visible leaks have been reported in some bags of ANTICOAGULANT SODIUM CITRATE SOLUTION, USP 4g/100mL. Products from the affected lots were distributed by Fresenius Kabi Canada Ltd in Canada beginning on December 30, 2025. Fresenius Kabi Canada Ltd has determined that the leaks are caused by manufacturing-related defects, including sealing defects, lamination issues, channel leaks and leaks involving the twist-off (butterfly) port. No design-related defect has been identified. Fresenius Kabi Canada Ltd is implementing corrective and preventative measures to address these manufacturing issues and prevent reoccurrence. To date, Fresenius Kabi Canada Ltd has not received any reports of adverse events associated with this issue, nor received any complaints related to potential microbiological contamination with the affected lots. In consultation with Health Canada, the affected lots identified in Appendix 1 are not being recalled at this time, as risk mitigation measures are available to detect leaking bags prior to use and recalling the affected lots could significantly disrupt plasma collection operations. Information for healthcare professionals Healthcare professionals are advised of the following: Regardless of the lot, inspect each bag prior to use by removing the overwrap and squeezing the inner bag firmly to check for small leaks, as directed on the product label (see Appendix 2 for the full product label). Discard the bag if it is observed to be leaking or damaged, or if the solution is not clear, because sterility may be impaired. Report any observed leaks, bag damage, or other product quality concerns to Fresenius Kabi Canada Ltd. Ensure that all relevant personnel in your organization are informed of this communication, including any consignees that may have received the product through your organization. Action taken by Health Canada Health Canada is communicating this important safety information to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication will be further distributed through the MedEffect™ e-Notice email notification system. Health Canada has requested Fresenius Kabi Canada Ltd, the market authorization holder for ANTICOAGULANT SODIUM CITRATE SOLUTION, USP 4g/100mL, to ensure that all affected healthcare professionals and personnel involved in the handling and administration of the product are informed of this communication and the recommended risk mitigation measures. Health Canada is monitoring the company’s implementation of any additional corrective and preventative actions. If additional safety information is identified, Health Canada will take appropriate action and inform Canadians as needed. Report health or safety concerns Managing marketed health product-related side effects depends on healthcare professionals and consumers reporting them. Any case of product-related adverse reactions associated with the use of ANTICOAGULANT SODIUM CITRATE SOLUTION, USP 4g/100mL should be reported to Fresenius Kabi Canada Ltd or Health Canada. Fresenius Kabi Canada Ltd165 Galaxy Blvd., Suite 100, Toronto, ON, M9W 0C8, Canada Phone: 1-877-779-7760Fax: 1-844-605-4465E-mail: Canada_Vigilance@fresenius-kabi.com For questions or concerns about ANTICOAGULANT SODIUM CITRATE SOLUTION, USP, please contact Fresenius Kabi Canada Ltd. at Canada_medinfo@fresenius-kabi.com OR by phone at 1-877-779-7760. Quality concerns can be reported to the Fresenius Kabi Canada Quality Complaints department at Canada_Product_Complaints@Fresenius-Kabi.com. Fresenius Kabi Canada Customer Service may be contacted toll-free at 1-877-821-7724. To correct your mailing address or fax number, contact Fresenius Kabi Canada Ltd. You can report any suspected adverse reactions associated with the use of health products to Health Canada by: • Calling toll-free at 1-866-234-2345; or• Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax. For other health product inquiries related to this communication, contact Health Canada at: Regulatory Operations and Enforcement BranchE-mail: hpce-cpsal@hc-sc.gc.ca Telephone: 1-800-267-9675 Original signed by: Prachi ChandelManager, Vigilance and Medical Affairs, National Safety Officer Appendix 1: Impacted Lot numbers Appendix 2: Product LabelAppendix 2a: ANTICOAGULANT SODIUM CITRATE SOLUTION, USP, 250 mL (Product Code: C6B7801) – Overwrap Label Appendix 2b: ANTICOAGULANT SODIUM CITRATE SOLUTION, USP, 250 mL (Product Code: C6B7801) – Shipper Label Appendix 2c: ANTICOAGULANT SODIUM CITRATE SOLUTION, USP, 250 mL (Product Code: C6B7801) – Hot Plate Label

What you should do

• See Key Messages below