Class II
Terminated
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.
This recall has been terminated (originally issued June 20, 2012).
- Company
- Luitpold Pharmaceuticals, Inc.
- Recall Initiated
- March 15, 2011
- Posted
- June 20, 2012
- Recall Number
- D-1378-2012
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 30 mL: 2,078,800 vials; 100 mL: 167,100 vials
- Firm Location
- Shirley, NY, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed.
Distribution
Nationwide, Puerto Rico, and Abu Dhabi
Lot / 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
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