FDA Drug recall 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…
- FDA Drug
- Class II
- terminated
- Published 2012-06-20
On 2012-06-20 the FDA classified a Class II recall of 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… by Luitpold Pharmaceuticals, citing presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1378-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-03-15 |
| Published | 2012-06-20 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Luitpold Pharmaceuticals |
| Distribution | US |
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.
Reason
Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed.
Identifiers
| code_info | 30 mL Lots: 9198, 9252, 9299, 9305, 9402, 9423, 9432, 9553, 9595, 9646, 9681, 9737, 9797, 9831, 0051, 0095, 0362;…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1378-2012%22
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