Magnesium Chloride 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 Magnesium Chloride Injection, MAGNESIUM CHLORIDE 20% INJECTABLE, For IV Use, 50 mL Multi-dose Vial, Rx only, Axia Pharm…

Recall number

D-0964-2020

FDA classification

Class III

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 III means the product violates regulations but is not likely to cause harm.

What was recalled

Magnesium Chloride Injection, MAGNESIUM CHLORIDE 20% INJECTABLE, For IV Use, 50 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0225-5