Baxter Healthcare Corporation recalls Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Sing…

Recall date

August 1, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0649-2024

FDA classification

Class I

Brand / firm

Baxter Healthcare Corporation

Sold / distributed

Nationwide in the USA

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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