Recall: SCA Pharmaceuticals Furosemide 100 Mg In 0.9% Sodium Chloride
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.
Company Contact Information:
Name: SCA Pharmaceuticals
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
Additional information provided by the FDA.gov:
For Immediate Release
September 6, 2018
Matt White, Pharm. D.
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||
|20180713@19||10/5/2018||97||7/26/18 - 7/31/18|
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:
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
Latest Safety Recalls
Select image for details, including additional styles.
Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.