Recall archive / FDA drug enforcement
Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbi... — FDA record D-0364-2023
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 23, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Nephron Sc Inc
- Quantity
- 325,080 vials
- Agency-reported status
- Terminated
- Source record identifier
- D-0364-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot #: 224011, 224021, 224022, 224023 Exp 12/31/2023 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
United States
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Mar 8, 2023
- Recall initiation date
- Feb 23, 2023
- Center classification date
- Mar 1, 2023
- Termination date
- Oct 11, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.