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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