Drug recall
0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Only, Nephron Pharmaceuticals…
FDA recall event 91449 · Class II · Nephron Sc Inc
Key facts
| Event ID | 91449 |
|---|---|
| Recall numbers | D-0177-2023, D-0178-2023 |
| Recalling firm | Nephron Sc Inc |
| Product type | Drugs |
| Products | 0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th St. Extension, W. Columbia, SC 29172, NDC: 0487-4301-10, UPC 3 04874…, Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x 5 mL Single-Dose Vials per carton, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th Street… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | CGMP Deviations: potential for trace amounts of product carryover. |
| Initiation date | Jan 12, 2023 |
| Report date | Feb 1, 2023 |
| Termination date | Oct 11, 2024 |
| City | West Columbia |
| State | SC |
| Country | United States |
| FEI number | 3010892830 |
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: