Sterile Water for Injection — Class II drug recall D-0364-2023
Terminated recall by Nephron Sc Inc, reported 2023-03-08. CGMP Deviations: Potential product carryover.
| Recall number | D-0364-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nephron Sc Inc, West Columbia, SC, United States |
| Recall initiated | 2023-02-23 |
| Classified | 2023-03-01 |
| Reported by FDA | 2023-03-08 |
| Terminated | 2024-10-11 |
| Quantity | 325,080 vials |
| Reason classes | cgmp |
| NDC | 00487-6105, 00487-6105-01 |
| Lot numbers | 224011, 224021, 224022, 224023 |
| Expiration dates | 2023-12-31 |
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 for recall
CGMP Deviations: Potential product carryover.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0364-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.