FDA recall D-0649-2024

Product

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

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2024-08-01

Report date

2024-09-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Round Lake, IL, United States

Primary source

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