Arginine Hydrochloride Injection recalled over sterility concerns

Recall date

January 15, 2020

Source

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

Official notice title

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical recalls Arginine Hydrochloride Injection, L-ARGININE HCL 100MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, A…

Recall number

D-0959-2020

FDA classification

Class II

Brand / firm

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Sold / distributed

U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

Why it was recalled

Lack of Assurance of Sterility

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

What was recalled

Arginine Hydrochloride Injection, L-ARGININE HCL 100MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0341-3