SCA Pharmaceuticals, Inc. recalls Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection, 100 mL Single Dose Container bag, Rx Only, SCA Pharma…

Recall date

August 27, 2018

Source

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

Recall number

D-1189-2018

FDA classification

Class I

Brand / firm

SCA Pharmaceuticals, Inc.

Sold / distributed

Three hospitals in DC, VA, CT

Why it was recalled

Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.

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

Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection, 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205, 877.550.5059, barcode 70004063032.