CONCENTRATED SODIUM CHLORIDE INJECTION — Class II drug recall D-1378-2012
Terminated recall by Luitpold Pharmaceuticals, Inc., reported 2012-06-20, distributed nationwide. Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed.
| Recall number | D-1378-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Luitpold Pharmaceuticals, Inc., Shirley, NY, United States |
| Recall initiated | 2011-03-15 |
| Classified | 2012-06-14 |
| Reported by FDA | 2012-06-20 |
| Terminated | 2018-06-28 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 00517-2900-25, 00517-2930-25 |
| Lot numbers | 0007, 0051, 0058, 0095, 0362, 100, 9198, 9225, 9252, 9299, 9305, 9402, 9423, 9432, 9492, 9553, 9595, 9646, 9681, 9711, 9737, 9797, 9831 |
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 for recall
Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1378-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.