FDA-Drug2023-02-01Class II

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.

Nephron Sc Inc
Hazard

CGMP Deviations: potential for trace amounts of product carryover.

Sold states
Nationwide in the USA
Affected count
389,730 vials
Manufactured in
4500 12th Street Ext, N/A, West Columbia, SC, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0178-2023

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