NDC 16729-275
Bivalirudin 250 mg per 5 mL injection, powder, lyophilized, for solution
On the label: Accord Healthcare Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it and tests it | No problems foundJul 12, 2024 · 10 inspections |
| Intas Pharmaceuticals Limited | Ahmedabad, India | Makes it and tests it | Serious problems, FDA actionDec 2, 2022 · 7 inspections, 1 with FDA action |
Recalls
- Jul 3, 2023 · Class II · Accord Healthcare, Inc.
Presence of Particulate Matter: Particulate matter identified as fiber.
Lots: Lot #: M2212070 Exp. date 08/2024
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Bivalirudin: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- 250 mg per 5 mL
- Approval
- ANDA ANDA206551
- On the market since
- Nov 7, 2018
- Package NDCs
16729-275-0316729-275-67- Official label
- DailyMed (National Library of Medicine), updated Aug 15, 2024
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