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.

FDA recall notice · announced June 20, 2012 · Luitpold Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Reason for recall

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

Notes

Distribution: Nationwide, Puerto Rico, and Abu Dhabi
Lot/code information: 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
Quantity: 30 mL: 2,078,800 vials; 100 mL: 167,100 vials
Status: Terminated
Products in this recall event:
- 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. (D-1378-2012)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.