American Regent Recalls Sodium Chloride and Dexamethasone Injections

American Regent announced a voluntary nationwide recall of concentrated sodium chloride injection, bacteriostatic sodium chloride injection, and dexamethasone sodium phosphate injection. This recall was initiated because some of these products may contain visible particulates. The following products and lots are being recalled:

Concentrated Sodium Chloride Injection, USP, 23.4%, 30mL Single Dose Vial, NDC # 0517-2930-25
  • Lot #s: 9198, 9252, 9299, 9305, 9402, 9423, 9432, 9553, 9595, 9646, 9681, 9737, 9797, 9831, 0051, 0095

Concentrated Sodium Chloride Injection, USP, 23.4%, 100mL Pharmacy Bulk Package, NDC # 0517-2900-25
  • Lot #s: 9225, 9492, 9711, 0007, 0058

Bacteriostatic Sodium Chloride Injection, USP, 0.9%, 30mL, Multiple Dose Vials, NDC # 0517-0648-25
  • Lot #s: 9330, 9599, 9828
 
Dexamethasone Sodium Phosphate Injection, 4mg/mL, 1mL Single Dose Vials, NDC # 0517-4901-25
  • Lot #s: 9153, 9170, 9182, 9218, 9254, 9295, 9329, 9352, 9368, 9385, 9422, 9425, 9441, 9512, 9549, 9565, 9605, 9615, 9615A, 9656, 9668, 9690, 9710, 9722, 9743, 0135, 0138, 0164, 0215, 0229, 0245, 0271, 0277, 0282, 0296, 0302, 0305, 0324, 0331, 0342, 0409, 0444, 0593, 0599, 0639, 0678, 0710, 0736, 0773, 0792, 0803, 0819, 0836, 0846, 0853, 0879
 
Dexamethasone Sodium Phosphate Injection, 4mg/mL, 5mL Multiple Dose Vials, NDC # 0517-4905-25
  • Lot #s: 9210, 9250, 9335, 9393, 9417, 9516, 9571, 9620, 9667, 0157, 0217, 0269, 0317, 0392, 0404, 0407, 0556, 0624, 0704, 0765, 0805, 0878, 1055
 
Dexamethasone Sodium Phosphate Injection, 4mg/mL, 30mL Multiple Dose Vials, NDC # 0517-4930-25
  • Lot #s: 0213, 0306, 0387, 0565, 0679, 0771, 0840
 
Hospitals, emergency rooms, infusion centers, clinics, physician offices and other healthcare providers and facilities should not use these recalled products. As is standard practice, all parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

For more information call (877( 788-3232 or visit www.americanregent.com.