feedback
facebook page
Follow Me on Pinterest
twitter page
google plus page
rss feed

Recalled Product

Item detail and remedy information

Search Recalls or Browse by Category
Consumer Products (?)
Food & Health (?)
Vehicles (?)
Home > Recalled Products > Drugs > Presence of Precipitate > SCA Pharmaceuticals Furosemide 100 Mg In 0.9% Sodium Chloride

Recall: SCA Pharmaceuticals Furosemide 100 Mg In 0.9% Sodium Chloride

email
email

On 2018-09-06, the FDA announced that SCA Pharmaceuticals is conducting a recall on Furosemide 100 Mg In 0.9% Sodium Chloride due to a possible presence of precipitate. The recalled products were sold under the brand name(s) SCA Pharmaceuticals during an unspecified time period throughout the regions shown in the map below.

In recent months, there have been 1 drugs recalls due to potential presence of precipitate. Additionally, there have been 29 drug and medical device recalls due to other health hazards as well as 71 food recalls.

Email Me About Recalls On:
Food  |  Drugs  |  Medical Devices  |  Pet Care Products  |  All of These


Furosemide 100 mg in 0.9% Sodium Chloride 100 mL bag, Product Label
Note: Images may not be available for every version. Please review the detailed description below.

Company Contact Information:

Name: SCA Pharmaceuticals
Phone: 877-550-5059

Do you work for a company involved with this recall? Contact us to learn how you can control data, information and ads shown on this page.

Detailed Recall Information



Regions Where Sold: Connecticut, Virginia and Washington

Product Description: Furosemide 100 mg in 0.9% Sodium Chloride

Brand Name(s): SCA Pharmaceuticals

Reason for Recall: Presence of Precipitate

Official Recall Date: 2018-09-06


Advertisement

Additional information provided by the FDA.gov:

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

For Immediate Release
September 6, 2018

Contact
Consumers

877-550-5059

Media
Matt White, Pharm. D.
877-550-5059

Announcement

SCA Pharmaceuticals LLC ("SCA Pharma") is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

Administration of a drug product that may contain precipitate has the potential to result in serious adverse events due to dosages that may be lower than intended and could lead to therapeutic failures. Intravenous administration of a product with the precipitate can result in blockage of blood vessels and/or catheter occlusions which could result in adverse events ranging from inflammation at the site of injection to more serious events that could include the formation of a blood clot obstructing the flow of blood which could lead to permanent lung damage.

SCA Pharmaceuticals has received one (1) customer complaint reporting the presence of precipitate. To date, no adverse events have been reported. Conservatively, the firm is voluntarily recalling seven (7) lots of the same product that are within their Beyond Use Date. These lots are listed in the table below:

Product Name Product Number Type of Packaging Indication SCA Lot Number Beyond Use Date Quantity Shipped Date(s) Distributed
Furosemide 100 mg in
0.9% Sodium Chloride
100 mL bag
70004-0630-32 100 mL IV bag








Diuretic
20180711@18 10/3/2018 106 7/24/18
20180712@19 10/4/2018 340 7/24/18
20180712@21 10/4/2018 341 7/24/18
20180712@24 10/4/2018 248 7/24/18
20180713@19 10/5/2018 97 7/26/18 - 7/31/18
20180727@21 10/19/2018 199 8/09/18
20180803@20 10/26/2018 53 8/14/18

This injectable product's indicated use and package type is identified in the table above. The lots associated with this recall were distributed to three hospitals in Connecticut, Virginia and Washington, D.C. The product can be identified by the following label:

SCA Pharmaceuticals is notifying the three customers via telephone, email and US mail and is arranging for return/replacement of all recalled product. Customers that have product which is being recalled, as indicated in the list above, should discontinue use immediately and return the product to SCA Pharmaceuticals at the address below:

SCA Pharma
8821 Knoedl Ct.
Little Rock, AR 72205

Consumers with questions regarding this recall can contact SCA Pharmaceuticals at 877-550-5059 between the hours of 8:00 AM and 5:00 PM (Central Standard Time), Monday through Friday. Consumers should contact their physician or healthcare provider if they experienced any problems that may be related to using this drug product.

Adverse reactions or quality problems associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.


More information may be available at FDA.gov
Advertisement


Latest Safety Recalls

Select image for details, including additional styles.

 

Advertisement

Comments

Do you have comments or questions about this recall? Share them here.
Note: The recalling companies may not be monitoring these comments; they should be directed toward the public. Community Guidelines apply.
comments powered by Disqus
Back to Top



Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.

Search Recalled Products or Browse by Category
Consumer Products (?)
Food & Health (?)
Vehicles (?)
Latest Product Recalls
Consumers
Register Products
Check for Recalls
Find Resources
Brands & Retailers
Connect to Customers

Consignment Sales
Check Inventory
Install Recall Finder
Take Safety Pledge

Home Inspectors
Check Appliances
Developers
APIs & Feeds
Recall Search for Web
Recall Search for Mobile
Facebook Apps

Researchers
Product Recall Statistics
About
Company
Contact
Press
Blog

Social
Facebook
Twitter