Home / Recalls / Luitpold Pharmaceuticals, Inc. / D-1378-2012

D-1378-2012 Class II Terminated

Recalled by Luitpold Pharmaceuticals, Inc. — Shirley, NY

Recall Details

Product Type: Drugs
Report Date: June 20, 2012
Initiation Date: March 15, 2011
Termination Date: June 28, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 30 mL: 2,078,800 vials; 100 mL: 167,100 vials

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.

Distribution Pattern

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