FDA-Drug2024-09-11Class I

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
Hazard

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

Sold states
Nationwide in the USA
Affected count
44,208 containers
Manufactured in
25212 W Il Route 120, Round Lake, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0649-2024

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