FDA-Drug2012-06-20Class II
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.
Luitpold Pharmaceuticals, Inc.
Hazard
Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed.
Sold states
Nationwide, Puerto Rico, and Abu Dhabi
Affected count
30 mL: 2,078,800 vials; 100 mL: 167,100 vials
Manufactured in
One Luitpold Drive, P.O. Box 9001, Shirley, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1378-2012Don't want to check this manually?
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