FDA Drug recall D-0649-2024
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, R…
- FDA Drug
- Class I
- ongoing
- Published 2024-09-11
On 2024-09-11 the FDA classified a Class I recall of 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, R… by Baxter Healthcare, citing microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0649-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-08-01 |
| Published | 2024-09-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
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
Reason
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Identifiers
| ndc | 0338-0431-03 |
|---|---|
| ndc | 0338-0433-04 |
| ndc | 0338-0424-18 |
| ndc | 0338-0428-12 |
| code_info | Lot # N008235, Exp 8/31/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0649-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.