Amino Acid Injection / L-Arginine HCl recalled over sterility concerns

Recall date

October 9, 2019

Source

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

Official notice title

Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center recalls Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only…

Recall number

D-0150-2020

FDA classification

Class II

Brand / firm

Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center

Sold / distributed

Nationwide.

Why it was recalled

Lack of Assurance of Sterility; bags have potential to leak

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

What was recalled

Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-988-10