FDA Drug recall D-0178-2023
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…
- FDA Drug
- Class II
- terminated
- Published 2023-02-01
On 2023-02-01 the FDA classified a Class II recall of 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… by Nephron Sc, citing CGMP Deviations: potential for trace amounts of product carryover.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0178-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-01-12 |
| Published | 2023-02-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Nephron Sc |
| Distribution | US |
Product
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.
Reason
CGMP Deviations: potential for trace amounts of product carryover.
Identifiers
| upc | 304876105013 |
|---|---|
| ndc | 0487-6105-01 |
| code_info | Lots: 124081, 124082, Exp. 04/2023; 224031, Exp. 01/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0178-2023%22
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