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
D-0364-2023
Product summary
- Firm
- Nephron Sc Inc
- Event
- Event 91767
- Status
- Terminated
- Classification
- Class II
- Quantity
- 325,080 vials
- Official record key
drug-enforcement:D-0364-2023
Official wording
Reason: CGMP Deviations: Potential product carryover.
Code information: Lot #: 224011, 224021, 224022, 224023 Exp 12/31/2023
Distribution pattern: United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations