Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection, 100 mL Single Dose Container ba...
FDA Recall #D-1189-2018 — Class I — August 27, 2018
Product Description
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.
Recalling Firm
SCA Pharmaceuticals, Inc. — Little Rock, AR
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
1384 bags
Distribution
Three hospitals in DC, VA, CT
Code Information
Lots: 20180711@18, BUD: 10/3/2018; 20180712@19, 20180712@21, 20180712@24 BUD: 10/4/2018; 20180713@19, BUD: 10/5/2018; 20180727@21, BUD: 10/19/2018; 20180803@20, BUD: 10/26/2018
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated