FDA recall D-0364-2023
Nephron Sc Inc · Class II · drug
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.
Distribution
United States
Key facts
- Status
- Terminated
- Initiation date
- 2023-02-23
- Report date
- 2023-03-08
- Termination date
- 2024-10-11
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- West Columbia, SC, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0364-2023