Skip to content
Back to recalls
Drug FDA Class I Ongoing Contamination / non-sterility

Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose Container, Rx Only, Baxter USA, NDC 0338-0433-04

Baxter Healthcare Corporation Published Sep 11, 2024

Risk level

Class I

Dangerous or defective — could cause serious health problems or death.

Severity score 85/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Baxter Healthcare Corporation or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

Hazards

Endotoxin · primary

Affected products (1)

Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose Container, Rx Only, Baxter USA, NDC 0338-0433-04

HEPARIN SODIUM IN SODIUM CHLORIDE · 44,208 containers

NDC: 0338-0424, 0338-0431, 0338-0433, 0338-0428, 0338-0431-03, 0338-0433-04, 0338-0424-18, 0338-0428-12
Lot codes: N008235
Code info: Lot # N008235, Exp 8/31/2024

Affected areas

Nationwide

Timeline

  1. Initiated
    Aug 1, 2024
  2. Published
    Sep 11, 2024
Recall number
D-0649-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.