Drug recall D-0178-2023
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.
Reason for recall
CGMP Deviations: potential for trace amounts of product carryover.
Lots and codes
Lots: 124081, 124082, Exp. 04/2023; 224031, Exp. 01/2024
Recall details
- Recalling firm
- Nephron Sc Inc, West Columbia, SC
- Quantity
- 389,730 vials
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 12, 2023
- Terminated
- October 11, 2024
Related products
- Sterile Water – drug information
- NDC 0487-6105 Sterile Water · Water 1 mL/mL · Nephron Pharmaceuticals Corporation