Baxter Issues Voluntary Nationwide Recall of One Lot of Heparin Sodium in 0.9%
Sodium Chloride Injection Due to Potential for Elevated Endotoxin Levels
Baxter International Inc. is voluntarily recalling one lot of Heparin Sodium in 0.9% Sodium Chloride Injection to the consumer level due to the potential for elevated endotoxin levels based on issues related to the bacterial endotoxin test specific to lot number N008235.
Use of heparin with higher than acceptable endotoxin levels may lead to significant adverse health consequences ranging from febrile reactions to toxic shock, multi-organ failure and death. To date, Baxter has not received any reports of adverse events related to this issue.
Heparin Sodium in Sodium Chloride Injection is indicated as an anticoagulant to maintain catheter patency and is packaged in 2,000 USP units, 1,000mL in VIAFLEX Plus Plastic Container-1 unit per pouch. This issue affects one lot of product code that was distributed between March 12, 2023, and August 24, 2023, to healthcare facilities, wholesalers and distributors in the United States. The product code and lot number can be found on the individual product and shipping carton. See the table below for more information.
Baxter voluntarily sent an Urgent Drug Recall communication to all impacted customers for the impacted lot and is arranging for the return of all affected product. Customers should follow the instructions in the
Urgent Drug Recall letter to return the affected product. Customers with questions regarding this recall should contact Baxter Healthcare Center for Service at (888)-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday.
- Contacting Baxter Product Surveillance at the Baxter product feedback portal
at https://productfeedback.baxter.com or emailing Baxter at corporate_product_complaints_round_lake@baxter.com. - Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the preaddressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
No members of BeneCard PBF were affected by this recall.
Source: FDA
