Recalls / Class I
Class ID-0649-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Brand name
- Heparin Sodium In Sodium Chloride
- Generic name
- Heparin Sodium
- Active ingredient
- Heparin Sodium
- Route
- Intravenous
- NDCs
- 0338-0424, 0338-0431, 0338-0433, 0338-0428
- FDA application
- NDA018609
- Affected lot / code info
- Lot # N008235, Exp 8/31/2024
Why it was recalled
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 25212 W Il Route 120, Round Lake, Illinois 60073-9799
Distribution
- Quantity
- 44,208 containers
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-08-01
- FDA classified
- 2024-08-30
- Posted by FDA
- 2024-09-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0649-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.