drugs Class II Updated 2012-06-20

Luitpold Pharmaceuticals, Inc. recalls CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 30 mL Lots: 9198, 9252, 9299, 9305, 9402, 9423, 9432, 9553, 9595, 9646, 9681, 9737, 9797, 9831, 0051, 0095, 0362; 100 mL Lots: 9225, 9492, 9711, 0007, 0058
View official government recall

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