MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION recalled over labeling errors

Recall date

March 6, 2015

Source

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

Official notice title

Hospira Inc. recalls MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, N…

Recall number

D-1076-2015

FDA classification

Class I

Brand / firm

Hospira Inc.

Sold / distributed

Nationwide

Why it was recalled

Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the immediate container that scans as heparin sodium 2000 USP units/1000 mL in 0.9% in sodium chloride injection.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6727-23, UPC (01) 0 030409 672723 1.