Drug 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
D-0649-2024
Product summary
- Event
- Event 95102
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 44,208 containers
- Official record key
drug-enforcement:D-0649-2024
Official wording
Reason: Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Code information: Lot # N008235, Exp 8/31/2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Microbial contamination
Microbial Contamination