Luitpold Pharmaceuticals, Inc. recalls CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL SINGLE DOSE VIAL, (NDC 0517-2930-25), b) 100 mL PHARMACY B
Recalled June 20, 2012 · FDA recall D-1378-2012 · Luitpold Pharmaceuticals
Hazard
Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed. · FDA Class II
Units
30 mL: 2,078,800 vials; 100 mL: 167,100 vials
Sold at
Nationwide, Puerto Rico, and Abu Dhabi
Description
Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed.
Product
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.
Manufacturer(s)
Luitpold Pharmaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →