Sterile Water for Injection recalled over manufacturing violations

Recall date

January 12, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Nephron Sc Inc recalls Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x 5 mL Single-Dose V…

Recall number

D-0178-2023

FDA classification

Class II

Brand / firm

Nephron Sc Inc

Sold / distributed

Nationwide in the USA

Why it was recalled

CGMP Deviations: potential for trace amounts of product carryover.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.