FDA Recall D-1189-2018

SCA Pharmaceuticals, Inc. · Little Rock, AR

Class I — life-threatening Terminated 645 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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.

Lot / code: 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

Quantity: 1384 bags

Reason for recall

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

Recall record

Recall number: D-1189-2018
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Three hospitals in DC, VA, CT
Recall initiated: 2018-08-27
Classified by FDA Center: 2018-09-12
FDA published: 2018-09-19
Terminated: 2020-06-02
Recalling firm: SCA Pharmaceuticals, Inc.
Firm location: Little Rock, AR

‹ All recalls