← FDA ENFORCEMENT
D-0649-2024Class I

Baxter Healthcare Corporation

Recalling firm
Baxter Healthcare Corporation
Product type
Drug
Status
Ongoing
Report date
2024-09-11
Distribution
Nationwide in the USA
Firm state
IL
Product quantity
44,208 containers
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

Product description

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

Code / lot info

Lot # N008235, Exp 8/31/2024

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.