NDC 52584-540
Heparin Sodium 1000 [USP'U] per 1 mL injection, solution
On the label: General Injectables & Vaccines, Inc.. It's repackaged: General Injectables & Vaccines, Inc. rebottles it from Fresenius Kabi, LLC's NDC 63323-540.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi USA, LLC | Grand Island, NY, United States | Makes it and tests it | Problems found, fixed voluntarilyOct 13, 2023 · 14 inspections, 2 with FDA action |
| Fresenius Kabi USA, LLC | Melrose Park, IL, United States | Makes it and tests it | Problems found, fixed voluntarilyAug 24, 2023 · 13 inspections, 2 with FDA action |
Repackaging site
- General Injectables & Vaccines, Inc., Location not on file · relabels it
Recalls
- Jan 22, 2014 · Class II · Fresenius Kabi USA, LLC
Subpotent; 18 month time point
Lots: Lot Number: 6004137, Expiration date: 06/2014
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
- Strength
- 1000 [USP'U] per 1 mL
- Approval
- NDA NDA017029
- On the market since
- Aug 1, 2010
- Package NDCs
52584-540-01- Official label
- DailyMed (National Library of Medicine), updated Jan 16, 2017
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