Drug product
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.
D-1378-2012
Product summary
- Event
- Event 58410
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 mL: 2,078,800 vials; 100 mL: 167,100 vials
- Official record key
drug-enforcement:D-1378-2012
Official wording
Reason: Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed.
Code information: 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
Distribution pattern: Nationwide, Puerto Rico, and Abu Dhabi
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter