D-0649-2024 Class I Ongoing

Recalled by Baxter Healthcare Corporation — Round Lake, IL

Recall Details

Product Type
Drugs
Report Date
September 11, 2024
Initiation Date
August 1, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
44,208 containers

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

Reason for Recall

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

Distribution Pattern

Nationwide in the USA

Code Information

Lot # N008235, Exp 8/31/2024