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Recall Observatory FDA recall evidence

Drug 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.

D-1189-2018

August 27, 2018

Class I

Product summary

Firm
SCA Pharmaceuticals, Inc.
Event
Event 80915
Status
Terminated
Classification
Class I
Quantity
1384 bags
Official record key
drug-enforcement:D-1189-2018

Official wording

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

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

Distribution pattern: Three hospitals in DC, VA, CT

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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