CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL SINGLE DOSE VIAL, (NDC 0517-2930-25...
FDA Recall #D-1378-2012 — Class II — March 15, 2011
Product Description
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.
Recalling Firm
Luitpold Pharmaceuticals, Inc. — Shirley, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
30 mL: 2,078,800 vials; 100 mL: 167,100 vials
Distribution
Nationwide, Puerto Rico, and Abu Dhabi
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated