Drug product
0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th St. Extension, W. Columbia, SC 29172, NDC: 0487-4301-10, UPC 3 04874 30110 3.
D-0177-2023
Product summary
- Firm
- Nephron Sc Inc
- Event
- Event 91449
- Status
- Terminated
- Classification
- Class II
- Quantity
- 378 bags
- Official record key
drug-enforcement:D-0177-2023
Official wording
Reason: CGMP Deviations: potential for trace amounts of product carryover.
Code information: Lot: 271043, Exp. 03/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations