MAGNESIUM Sulfate added to 0 recalled over sterility concerns

Recall date

July 14, 2017

Source

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

Official notice title

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

Recall number

D-1003-2017

FDA classification

Class II

Brand / firm

SCA Pharmaceuticals

Sold / distributed

Nationwide in the USA

Why it was recalled

Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.

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 4 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0737-32.