FDA Drug recall D-0364-2023
Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbia, SC 29172, NDC 0487-…
- FDA Drug
- Class II
- terminated
- Published 2023-03-08
On 2023-03-08 the FDA classified a Class II recall of Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbia, SC 29172, NDC 0487-… by Nephron Sc, citing CGMP Deviations: Potential product carryover.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0364-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-02-23 |
| Published | 2023-03-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Nephron Sc |
| Distribution | n/a |
Product
Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbia, SC 29172, NDC 0487-6105-01
Reason
CGMP Deviations: Potential product carryover.
Identifiers
| ndc | 0487-6105-01 |
|---|---|
| code_info | Lot #: 224011, 224021, 224022, 224023 Exp 12/31/2023 |
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-0364-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.