MAGnesium 4gm in NS 4 gm recalled over sterility concerns

Recall date

June 12, 2018

Source

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

Official notice title

Avella of Deer Valley, Inc. Store 38 recalls MAGnesium 4gm in NS 100 mL (MAGnesium SULfate (USP) 4 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 108 mL. Single do…

Recall number

D-0936-2018

FDA classification

Class II

Brand / firm

Avella of Deer Valley, Inc. Store 38

Sold / distributed

Nationwide in the USA

Why it was recalled

Lack of Assurance of Sterility: Potential leakage of bags.

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

What was recalled

MAGnesium 4gm in NS 100 mL (MAGnesium SULfate (USP) 4 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 108 mL. Single dose bag. For: Gaston Memorial Hospital By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-905-10