Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Singl
Summary
The FDA issued a Class I for Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,00 by Baxter Healthcare Corporation. Reason: Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing..
Details
Source
Drug Recall
External ID
D-0649-2024
Action Date
2024-09-11
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot # N008235, Exp 8/31/2024
Quantity Affected: 44,208 containers
Reason for Recall
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-01
Company
Round Lake, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 36 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Baxter Healthcare Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Baxter Healthcare Corporation have FDA actions?
Baxter Healthcare Corporation has 310 FDA actions in our database, including 286 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0649-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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