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Class I · Most seriousActive recall

Heparin Sodium In Sodium Chloride

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLot # N008235, Exp 8/31/2024
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byBaxter Healthcare Corporation
Brand nameHEPARIN SODIUM IN SODIUM CHLORIDE
Generic nameHEPARIN SODIUM
Active ingredient(s)HEPARIN SODIUM
Distributed by / forBaxter Healthcare Corporation
NDC0338-0433-04
Show the full FDA record
Full product labelHeparin (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
Recalling firmBaxter Healthcare Corporation
DistributionNationwide in the USA
Quantity44,208 containers
Recall initiated2024-08-01
Report date2024-09-11
Recall completed
Recall numberD-0649-2024
ClassificationClass I
FDA statusOngoing
Origin on fileRound Lake IL United States

Related

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.