Drug product
Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x 5 mL Single-Dose Vials per carton, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th Street Extension, W. Columbia, SC 29172, NDC 0487-6105-01, UPC 3 04876 10501 3.
D-0178-2023
Product summary
- Firm
- Nephron Sc Inc
- Event
- Event 91449
- Status
- Terminated
- Classification
- Class II
- Quantity
- 389,730 vials
- Official record key
drug-enforcement:D-0178-2023
Official wording
Reason: CGMP Deviations: potential for trace amounts of product carryover.
Code information: Lots: 124081, 124082, Exp. 04/2023; 224031, Exp. 01/2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations