– American Regent Initiates Voluntary Nationwide Recall of Bacteriostatic Sodium Chloride Injection, USP, 0.9% 30 mL Multiple Dose Vials [1] These are multiple dose vials , but only for use on a single patient on a single day. This voluntary recall was initiated because some of the vials of these lots may contain visible particulates. Potential adverse events after intravenous administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness due to accumulation of inflammatory cells), and granuloma formation. American Regent is undertaking this voluntary recall in consideration of the potential for safety issues if these lots of product are administered to patients. [1] They do not mention disruption of blood flow to the small vessels of the brain because the lungs are expected to filter out these particles before they reach the brain. – As is standard practice, and as stated in the Bacteriostatic Sodium Chloride Injection, USP Product Package Insert, “Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.” [1] Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. This should be true for everything we inject. – But these are not the only vials by American Regent being recalled – American Regent Initiates Voluntary Nationwide Recall of Concentrated Sodium Chloride Injection, USP, 23.4% 30 mL Single Dose Vials and 100 mL Pharmacy Bulk Packs [2] What is the difference between the 0.9% and the 23.4% 30 mL vials? Bacteriostatic Sodium Chloride Injection, USP, 0.9% is used for preparing and diluting sterile solutions. [1] The 30 mL 0.9% (Normal Saline) solution is below. – Concentrated Sodium Chloride Injection, USP, 23.4% is indicated as an additive in parenteral fluid therapy for use in patients who have special problems of sodium electrolyte intake or excretion. It is intended to meet the specific requirement of the patient with unusual fluid and electrolyte needs. [2] The 30 mL concentrated solution is below. – It should be easier to tell the more concentrated solution from the others, since it is much larger. The 100 mL concentrated solution is below. – Footnotes: – [1] American Regent Initiates Voluntary Nationwide Recall of Bacteriostatic Sodium Chloride Injection, USP, 0.9% 30 mL Multiple Dose Vials FDA Recalls, Market Withdrawals, & Safety Alerts Recall notice – [2] American Regent Initiates Voluntary Nationwide Recall of Concentrated Sodium Chloride Injection, USP, 23.4% 30 mL Single Dose Vials and 100 mL Pharmacy Bulk Packs FDA Recalls, Market Withdrawals, & Safety Alerts Recall notice .

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