Recall archive / FDA company announcement

Baxter: Heparin Sodium in 0.9% Sodium Chloride Injection — FDA announcement Aug 6, 2024

Published notice; closure not supplied

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Aug 6, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Heparin Sodium in 0.9% Sodium Chloride Injection
Reason: Elevated endotoxin levels
Classification: Not supplied
Recalling firm: Baxter International Inc
Quantity: Not supplied
Agency-reported status: Company recall announcement
Source record identifier: 36617ea592721fbf

Open the official record

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	FOR IMMEDIATE RELEASE - DEERFIELD, Ill., AUG. 5, 2024 – 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.; 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. See the product image below for more on where this information can be found.; 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.; 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

Label field

Details supplied by the agency

Lot, code or applicability

FOR IMMEDIATE RELEASE - DEERFIELD, Ill., AUG. 5, 2024 – 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.; 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. See the product image below for more on where this information can be found.; 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.; 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

Match all identifying details in the current notice. A brand name alone is not enough.

Product tables from the announcement

These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.

FDA company announcement, table 1
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

Announcement retrieved Oct 1, 2026. Official announcement.

Distribution

Not supplied

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Fda listing date: Aug 6, 2024
Company announcement date: Aug 5, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.