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

FDA recall notice · announced September 11, 2024 · Baxter Healthcare

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot # N008235, Exp 8/31/2024
Quantity: 44,208 containers
Status: Ongoing
Products in this recall event:
- 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 (D-0649-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.