Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL)...
FDA Recall #D-0649-2024 — Class I — August 1, 2024
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.
Recalling Firm
Baxter Healthcare Corporation — Round Lake, IL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
44,208 containers
Distribution
Nationwide in the USA
Code Information
Lot # N008235, Exp 8/31/2024
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated