Baxter International has issued voluntary recalls of one lot each of 70% Dextrose Injection and Anticoagulant Sodium Citrate Solution after identifying particulate matter in the products.
The company is recalling 70% Dextrose Injection, USP, in 2,000-milliliter VIAFLEX plastic containers because of the potential presence of stainless-steel particles. Separately, it is recalling Anticoagulant Sodium Citrate Solution, USP, in 250-milliliter VIAFLEX plastic containers over potential fiberglass contamination.
Baxter announced both recalls Aug. 25 and said it had received no reports of adverse events related to either issue as of that date.
The affected 70% Dextrose Injection is product code 2B0296H, lot Y495066, with an expiration date of July 31, 2027, and National Drug Code 0338-0719-06. The lot was distributed from July 25 through July 28 to healthcare providers and distributors in Alabama, Georgia and Tennessee.
The dextrose product is used with amino acids or other compatible intravenous fluids to provide calories and fluid replenishment for patients requiring parenteral nutrition when oral or enteral feeding is not possible, inadequate or contraindicated.
Baxter said intravenous administration of solution containing stainless-steel particles could cause blood-vessel blockage or clotting, pulmonary embolism, permanent organ damage or death. The particles may also cause vein irritation, inflammation, aggravation of existing infections or allergic reactions.
The sodium citrate recall covers product code 2B7867Q, lot Y493475, expiring Dec. 31, 2027, with National Drug Code 0338-9669-01. The lot was distributed from July 2 through July 11 to one U.S. customer.
Sodium citrate solution is intended for use with automated apheresis devices and is not for direct intravenous infusion. Baxter said fiberglass particles, particularly in the absence of in-line filtration, could cause local vein irritation, inflammatory or hypersensitivity reactions, or systemic embolization resulting in tissue or organ injury.
The FDA has been notified of both recalls.
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