Drug recall
Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC…
FDA recall event 73395 · Class II · Nephron Pharmaceuticals Corp.
Key facts
| Event ID | 73395 |
|---|---|
| Recall numbers | Z-2053-2016, Z-2054-2016 |
| Recalling firm | Nephron Pharmaceuticals Corp. |
| Product type | Devices |
| Products | Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC 0487-9003-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as…, Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, NDC 0487-9007-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial. |
| Initiation date | Nov 16, 2015 |
| Report date | Jul 6, 2016 |
| Termination date | Jan 9, 2017 |
| City | Orlando |
| State | FL |
| Country | United States |
| FEI number | 1000114235 |
At a glance
- 1–9 Products in this recall
- None 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: