According to the FDA, Baxter International Inc., of Deerfield, Illinois, has recalled lot number N008235 of its Heparin Sodium in 0.9% Sodium Chloride Injection after issues with a bacterial endotoxin test revealed a potential for elevated endotoxin levels in the batch.
Consumers are warned that use of heparin containing levels of endotoxin exceeding the approved amount may put them at risk for major adverse health outcomes that include “toxic shock, multi-organ failure and death.”
Indicated as an anticoagulant to keep a catheter open and unblocked for increased functionality, Heparin Sodium in Sodium Chloride Injection comes packaged in 2,000 USP units, 1,000 mL in a VIAFLEX Plus Plastic Container with 1 unit per pouch.
Announced by Baxter on August 5, 2024, the voluntary recall impacts products under lot code N008235 and Expiry Date “31-Aug-2024” that were distributed from March 12, 2023, to August 24, 2023, to healthcare facilities as well wholesale partners and distributors across the U.S. Consumers are able to locate the product code and lot number on each finished product and shipping carton, as shown in the product photo included in the FDA announcement.
At the time of the August 6, 2024 FDA announcement, Baxter has not been made aware of any reports of illness in connection to the issue, but all impacted customers were sent an Urgent Drug Recall communication with instructions for the return of all affected products.
Further questions may be directed to Baxter Healthcare Center for Service at (888) 229-0001, Monday through Friday, from 7:00 a.m. to 6:00 p.m. Central Time. Product quality complaints or reports of adverse events may be reported to Baxter Product Surveillance using the Baxter product feedback portal on the company webpage and designated email listed in the FDA announcement.
As the FDA continues to oversee this recall, consumers are also encouraged to report any related adverse experiences to the agency’s MedWatch program.
If you or a loved one has experienced an adverse health outcome as a consequence of using Heparin Sodium in 0.9% Sodium Chloride Injection, or any other medical drug, you deserve justice and fair compensation. Our attorneys at TruLaw are personally invested in defending consumer safety and holding negligent parties responsible for pain and suffering. To learn more about how we can support you through this time, contact us or take our free Instant Case Evaluation ℠.