Drug Enforcement D-0649-2024

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

Status

Ongoing

Classification

Class I

Report Date

September 11, 2024

Termination Date

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Product Information

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
Product quantity
44,208 containers
Reason for recall
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Baxter Healthcare Corporation
Address
25212 W Il Route 120

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0649-2024
Event ID
95102
Recall initiation date
August 1, 2024
Center classification date
August 30, 2024
Code info
Lot # N008235, Exp 8/31/2024
More code info
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