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U.S. Department of Health and Human Services

Enforcement Report - Week of June 20, 2012

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Product Detail

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.
Recall Number D-1378-2012
Classification Class II
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
Product Distributed Qty 30 mL: 2,078,800 vials; 100 mL: 167,100 vials
Reason For Recall Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed.

Event Detail

Event Id 58410
Product Type Drugs
Status Ongoing
Recalling Firm Luitpold Pharmaceuticals, Inc.
City Shirley
State NY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-03-15
Initial Firm Notification of Consignee or Public Press Release
Distribution Pattern Nationwide, Puerto Rico, and Abu Dhabi
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