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.

FDA recall notice · announced September 19, 2018 · Sca Pharmaceuticals

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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.

Notes

Distribution: Three hospitals in DC, VA, CT
Lot/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
Quantity: 1384 bags
Status: Terminated
Products in this recall event:
- 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 70004063 (D-1189-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.