The 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.
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.
The product was distributed to wholesalers and distributors nationwide.
Hospitals, infusion centers, clinics and other healthcare facilities should not use American Regent Inc., Concentrated Sodium Chloride Injection, USP, 23.4% with the lot #s on the attached Appendix for patient care and should immediately quarantine any product for return.
For a complete list of products affected by this recall see the link below.