FDA Recall TerminatedTerminated: June 28, 2018Historical recordClass II
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.
- Reason
- Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed.
- Published
- June 20, 2012
- Distribution
- Nationwide
