CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL SINGLE DOSE VIAL, (NDC 0517-2930-25), b) 100 mL PHARMACY BULK PACKAGE (NDC 0517-2900-25), Rx Only, AMERICAN REGENT, INC. SHIRLEY, NY 11967.

Recall Number: D-1378-2012

Firm: Luitpold Pharmaceuticals, Inc.

Classification: Class II

Status: Terminated

Report Date: 20120620

Initiation Date: 20110315

Termination Date: 20180628

Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed.

CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL SINGLE DOSE VIAL, (NDC 0517-2930-25), b) 100 mL PHARMACY BULK PACKAGE (NDC 0517-2900-25), Rx Only, AMERICAN REGENT, INC. SHIRLEY, NY 11967.