August 2018 FDA Recall Drug by Sca Pharmaceuticals, Inc.
D-1189-2018 - Presence of Precipitate

This Class I drug recall was voluntarily initiated by Sca Pharmaceuticals, Inc. on August 27, 2018 for the product Drug. The FDA reported the reason for recall as presence of precipitate. The product was distributed in Three hospitals in DC, VA, CT and the recall is currently terminated.

Recall Number: D-1189-2018

Reason for Recall
Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.
Initiated
08-27-2018
Reported
09-19-2018
Quantity
1384 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80915
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SCA Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Three hospitals in DC, VA, CT
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-02-2020
Product Description About Product Description
Full technical description of 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.

Batch or Lot Expiration Information

Lot# 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