Certain injectible products made by American Regent are being recalled because of visible particles in the solution. The particles were found to be glass delamination, which if injected into patients could cause serious health problems such as damage to blood vessels in the lungs, localized swelling and granuloma formation.

The recall involves  Bacteriostatic Sodium Chloride Injection, USP, 0.9%, 30 mL Multiple Dose Vials; Concentrated Sodium Chloride Injection, USP 23.4%, 30 mL Single Dose Vials and 100mL Pharmacy Bulk Packages; Sodium Thiosulfate Injection USP 10%; and Potassium Phosphates Injection, USP.

Bacteriostatic Sodium Chloride Injection is used in diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection. Concentrated Sodium Chloride Injection is indicated as an additive in parenteral fluid therapy for use in patients who have special problems of sodium electrolyte intake or excretion.

Sodium thiosulfate injection is used to treat cyanide poisoning. Potassium phosphates injection is used, as a source of phosphorus, for addition to large volume intravenous fluids to prevent or correct hypophosphatemia in patients with restricted or no oral intake.

The products are used by hospitals, home health care agencies, emergency rooms, infusion centers, clinics and other healthcare facilities. Customers have been notified by American Regent and urged to immediately quarantine the products for return.

Any side effects with these products should be reported by health care staff, patients or caregivers to the Food and Drug Administration MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.