MAGNESIUM Sulfate added to 0 recalled over sterility concerns

Recall date

May 18, 2017

Source

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

Official notice title

SCA Pharmaceuticals recalls MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total Approximate Volume 108 mL (does not includ…

Recall number

D-0878-2017

FDA classification

Class II

Brand / firm

SCA Pharmaceuticals

Sold / distributed

Nationwide in the USA

Why it was recalled

Lack of assurance of sterility: Product bags leaking at seam.

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 Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0737-32