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U.S. Department of Health and Human Services

Enforcement Report - Week of June 20, 2012

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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

Product Detail

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