Multi event Drug Recall Enforcement Report Class II voluntary initiated by Nephron Sc Inc, originally initiated on 01-12-2023 for the product 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 30110 3. The product was recalled due to cgmp deviations: potential for trace amounts of product carryover.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0177-2023 | 01-12-2023 | 02-01-2023 | Class II | 378 bags | 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 30110 3. | CGMP Deviations: potential for trace amounts of product carryover. | Terminated |
| D-0178-2023 | 01-12-2023 | 02-01-2023 | Class II | 389,730 vials | 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 Extension, W. Columbia, SC 29172, NDC 0487-6105-01, UPC 3 04876 10501 3. | CGMP Deviations: potential for trace amounts of product carryover. | Terminated |
Recalled Products
