Nephron Sc product 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 0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Only, Nephron Pharmaceuticals Corporation, 45…

Recall number

D-0177-2023

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

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.