D-1189-2018 Class I Terminated
FDA drug recall D-1189-2018 was initiated by SCA Pharmaceuticals, Inc. on Aug 27, 2018 and is designated Class I. Reason for recall: Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide. The recall status is terminated (terminated Jun 2, 2020). Affected quantity: 1384 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 19, 2018
- Initiation Date
- Aug 27, 2018
- Termination Date
- Jun 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1384 bags
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.
Distribution Pattern
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1189-2018
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026