LACTATED RINGER'S and 5% DEXTROSE Injection USP recalled over sterility concerns

Recall date

July 10, 2014

Source

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

Official notice title

Hospira Inc. recalls LACTATED RINGER'S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers, Rx Only, Hospira, Inc., Lake Forest, IL…

Recall number

D-0392-2015

FDA classification

Class I

Brand / firm

Hospira Inc.

Sold / distributed

Nationwide

Why it was recalled

Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary container, consistent with mold.

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

LACTATED RINGER'S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers, Rx Only, Hospira, Inc., Lake Forest, IL 600045, NDC 0409-7929-09