American Regent recalls Dexamethasone Sodium Phosphate Injection and Sodium Chloride Injection

March 31, 2011

American Regent, a division of Luitpold Pharmaceuticals in Shirley, N.Y., recently recalled several lots of Dexamethasone Sodium Phosphate Injection and Sodium Chloride Injection because they may contain particulates.

American Regent, a division of Luitpold Pharmaceuticals in Shirley, N.Y., recently recalled several lots of Dexamethasone Sodium Phosphate Injection and Sodium Chloride Injection because they may contain particulates.

Dexamethasone Sodium Phosphate Injection, a synthetic adrenocortical steroid used to treat allergies and inflammatory conditions, was recalled because the lots either contain particulates or have the potential to form particulates prior to their respective expiration dates, according to Luitpold Pharmaceuticals.

According to a statement from Luitpold, “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.”

The recalled Dexamethasone Sodium Phosphate Injection lots include 4 mg/mL, 1 mL single dose vials, NDC #0517-4901-25; 4 mg/mL, 5 mL multiple dose vials, NDC #0517-4905-25; and 4 mg/mL, 30 mL multiple dose vials, NDC #0517-4930-25.

American Regent also recalled concentrated Sodium Chloride Injection USP, because some of the vials may contain visible particulates. The injection is indicated as an additive in parenteral fluid therapy, for patients who have problems of sodium electrolyte intake or excretion. The recalled lots are 23.4%, 30 mL single dose vial, NDC # 0517-2930-25; and 23.4%, 100 mL pharmacy bulk package, NDC #0517-2900-25.

Certain lots of American Regent’s Bacteriostatic Sodium Chloride Injection USP were also recalled because of particulates. The recall applies to 0.9%, 30 mL multiple dose vials NDC #0517-0648-25 in lots 9330, 9599, and 9828. Bacteriostatic Sodium Chloride Injection is used to prepare and dilute sterile solutions.

Hospitals, clinics, and other healthcare facilities should not use the affected lots and should immediately quarantine affected product for return. Call American Regent at 877-788-3232 for questions on the recall or return process.