Sodium Chloride Injection Recalled

Concentrated <"">Sodium Chloride Injections have been recalled because some of the vials may contain visible particulates, said the U.S. Food and Drug Administration (FDA).

The recall involves the following two injections. Complete details on the lot numbers involved can be accessed on the FDA’s website:

• Concentrated Sodium Chloride Injection, USP, 23.4%, 30 mL Single Dose Vial NDC # 0517-2930-25

• Concentrated Sodium Chloride Injection, USP, 23.4%, 100 mL Pharmacy Bulk Package NDC # 0517-2900-25 are involved in this nationwide recall.

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.

Concentrated Sodium Chloride Injection, USP, 23.4% is indicated as an additive in parenteral fluid therapy for use in patients with special problems involving sodium electrolyte intake or excretion. This drug is intended to meet the specific requirement of the patient with unusual fluid and electrolyte needs and 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 numbers involved for patient care and should immediately quarantine any product for return.

American Regent has identified the source of the particulates and has taken the necessary steps to correct this issue including initiating this recall for the lots manufactured prior to the implementation of the corrective action. American Regent also advised the FDA of its actions and is maintaining ongoing discussions with the agency.

Of note, the Concentrated Sodium Chloride Injection, USP Product Package Insert states: “Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.”

American Regent will credit accounts for all returned product with the recalled lot numbers. American Regent’s Customer Service Department can be reached, toll-free, at 1.877.788.3232, Monday through Friday from 8:30 a.m. to 7:00 p.m., Eastern Time. The Professional Services Department can be reached at 1.877.788.3232.

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