NDC 0338-0428
Heparin Sodium In Sodium Chloride 200 [USP'U] per 100 mL injection, solution
On the label: Baxter Healthcare Corporation.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Baxter Healthcare Corporation | Marion, NC, United States | Makes it, tests it, packages it, labels it and sterilizes it | Serious problems, FDA actionFeb 9, 2024 · 9 inspections, 3 with FDA action |
| Baxter Healthcare Corporation | Jayuya, PR, United States | Makes it, tests it, packages it, labels it and sterilizes it | Problems found, fixed voluntarilyJul 19, 2024 · 15 inspections, 5 with FDA action |
| Baxter Healthcare Pty Ltd | Old Toongabbie, Australia | Makes it, tests it, packages it, labels it and sterilizes it | Problems found, fixed voluntarilyJul 5, 2022 · 1 inspection |
| Baxter Healthcare Corporation | Round Lake, IL, United States | Tests it | Serious problems, FDA actionApr 2, 2026 · 15 inspections, 2 with FDA action |
Recalls
- Aug 1, 2024 · Class I · Baxter Healthcare Corporation
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Lots: Lot # N008235, Exp 8/31/2024 - Jun 3, 2015 · Class II · Baxter Healthcare Corp
Subpotent Drug; out of specification results for heparin raw material
Lots: Product Code: 280953 Lots: N002998 and N003004 exp 12/31/15; and lot N003038 exp. 01/31/2016 - Oct 30, 2014 · Class II · Baxter Healthcare Corp.
Subpotent Drug: Heparin raw material was found to have low potency
Lots: Lot #: N003061; N003079; and N003087, Exp 2/29/2016 - May 21, 2013 · Class II · Baxter Healthcare Corp.
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
Lots: Lot #: a) Product code 2B0944: N001164, Exp 7/13; b) Product code 2B0953: N001396, Exp 11/13
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Heparin: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 200 [USP'U] per 100 mL
- Approval
- NDA NDA018609
- On the market since
- Apr 28, 1982
- Package NDCs
0338-0428-12- Official label
- DailyMed (National Library of Medicine), updated Jan 3, 2022
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