Drug recall
CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL SINGLE DOSE VIAL, (NDC 0517-2930-25), b) 100 mL…
FDA recall event 58410 · Class II · Luitpold Pharmaceuticals, Inc.
Key facts
| Event ID | 58410 |
|---|---|
| Recall numbers | D-1378-2012 |
| Recalling firm | Luitpold Pharmaceuticals, Inc. |
| Product type | Drugs |
| Products | 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. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of Particulate Matter: In the course of inspecting retention samples visual particles were observed. |
| Initiation date | Mar 15, 2011 |
| Report date | Jun 20, 2012 |
| Termination date | Jun 28, 2018 |
| City | Shirley |
| State | NY |
| Country | United States |
| FEI number | 2410375 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: