UPDATED INFORMATION – May 6, 2022 Further to the communication below, issued on March 15, 2022, regarding the potential for the presence of particulate matter in vials of Sodium Acetate Injection, USP (DIN 02139529) from lot 6126554, Fresenius Kabi Canada Ltd., in consultation with Health Canada, is providing updated information on the filters to be used with distributed vials from this affected lot. Healthcare professionals are reminded to carefully inspect all sodium acetate injectable products, regardless of the lot, before and after dilution and all intravenous bags. If particulate matter is observed, the product should NOT be administered. Healthcare professionals are advised, when using the affected lot of Sodium Acetate Injection, USP, to follow this updated information: For non-Total Parenteral Nutrition (TPN) therapies, use a 5 micron nylon filter needle to withdraw the required calculated volume of sodium acetate from the vial. When administering the final admixture to patients, use the most suitable filter among the following: A 0.22 micron or 1.2 micron polyethylenesulfone (PES) in-line filter, OR A 0.22 micron or 1.2 micron nylon in-line filter, OR A 0.45 micron or 1.2 micron acrylic copolymer in-line filter. For 2-in-1 (amino acids and carbohydrates) TPN therapies, use a 5 micron nylon filter needle to withdraw the required calculated volume of sodium acetate from the vial, then use a TPN-compatible 0.22 micron in-line filter to administer the final admixture. For 3-in-1 (lipid, amino acids, and carbohydrates) TPN therapies, use a 5 micron nylon filter needle to withdraw the required calculated volume of sodium acetate from the vial, then use a TPN-compatible 1.2 micron in-line filter to administer the final admixture. March 15, 2022 Fresenius Kabi Canada Ltd. has identified visible particulate matter in certain vials of Sodium Acetate Injection, USP from lot 6126554 during routine retention sample testing. The distributed vials from the affected lot are not being recalled due to shortages of this product. Particulate matter (greater than 5 microns) could potentially obstruct blood flow through capillaries. In the event that particulate matter is inadvertently injected into a patient, there is potential for patient injury, such as local inflammation, phlebitis, abscesses, granulomas in visceral organs, allergic response, infections at the injection site and/or embolization in the body. There have been no reports of adverse events to date for the affected lot.
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