Why it was recalled
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
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 numbers, UPCs & expiration codes
Lot # N008235, Exp 8/31/2024
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0649-2024
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Aug 1, 2024
- FDA report date
- Sep 11, 2024
- Quantity
- 44,208 containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corporation
Original FDA data
Every field from FDA enforcement report D-0649-2024, exactly as published.
Show all FDA fields
- City
- Round Lake
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 95102
- Address
- 25212 W Il Route 120
- Code information
- Lot # N008235, Exp 8/31/2024
- Postal code
- 60073-9799
- Report date
- Sep 11, 2024
- Product type
- Drugs
- Recall number
- D-0649-2024
- Classification
- Class I
- Recalling firm
- Baxter Healthcare Corporation
- Product quantity
- 44,208 containers
- Reason for recall
- Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 1, 2024
- Initial firm notification
- Letter
- Center classification date
- Aug 30, 2024