FDA recall D-1189-2018

Product

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.

Reason for recall

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

Distribution

Three hospitals in DC, VA, CT

Key facts

Status

Terminated

Initiation date

2018-08-27

Report date

2018-09-19

Termination date

2020-06-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Little Rock, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1189-2018