FDAFDA · Food and drugs·Recall number D-1378-2012
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.
Published June 20, 2012 · Recall initiated: March 15, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Luitpold Pharmaceuticals, Inc.
- Distributor
- Nationwide, Puerto Rico, and Abu Dhabi
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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