Baxter Recalls One Lot of Heparin Sodium 0.9% Sodium Chloride Injection
Medical Recalls
Heparin Sodium label
Baxter International Inc. (NYSE:BAX) 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, 1,000 mL 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.
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.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Source: FDA
You Are Leaving Us
This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.
Consumer Contact: -
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.
You Are Leaving Us
This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.
You Are Leaving Us
This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.
You Are Leaving Us
This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.
Product Code | Product Description | Lot Number | Expiry Date | NDC Number |
2B0944 | Heparin Sodium in 0.9% Sodium Chloride Injection, 2,000 units per 1,000 mL | N008235 | 31-Aug-2024 | 0338-0433-04 |
Related Posts
Latest Posts
Report a Problem With This Product
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.
- Complete and submit the report Online
- Regular Mail or Fax: Download form 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
- Complete a paper Voluntary MedWatch form that can be mailed to the FDA.
- https://www.fda.gov/safety/report-problem-fda
- Call an FDA Consumer Complaint Coordinator.
You Are Leaving Us
This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.
You Are Leaving Us
This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.
You Are Leaving Us
This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.
You Are Leaving Us
This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.
You Are Leaving Us
This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.