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
Reported: September 11, 2024 Initiated: August 1, 2024 #D-0649-2024
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.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 44,208 containers
- Distribution
- Nationwide in the USA
- Location
- Round Lake, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Baxter Healthcare Corporation. Units affected: 44,208 containers.
Why was this product recalled? ▼
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 11, 2024. Severity: Critical. Recall number: D-0649-2024.
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