D-1189-2018 Class I Terminated
FDA drug recall D-1189-2018 was initiated by SCA Pharmaceuticals, Inc. on August 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 June 2, 2020). Affected quantity: 1384 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- September 19, 2018
- Initiation Date
- August 27, 2018
- Termination Date
- June 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