NDC 72572-470
Nicardipine Hydrochloride 2.5 mg per 1 mL injection, solution
On the label: Civica, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| American Regent, Inc. | New Albany, OH, United States | Makes it | Problems found, fixed voluntarilyJan 29, 2026 · 5 inspections |
| American Regent, Inc. | Columbus, OH, United States | Tests it | Problems found, fixed voluntarilyMar 5, 2026 · 8 inspections |
Recalls
- Jul 24, 2026 · Class II · American Regent, Inc.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Lots: Lot #: 25295N0C0, Exp. Date: 04/30/2027. - Apr 18, 2025 · Class II · American Regent, Inc.
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Lots: Lots, expiry: Lot 24025N0C0, 6/30/2025; Lot 24115N0C0, 10/31/2025; Lot 24116N0C0, 3/31/2026; Lot 24160N0C0, 12/31/2025; Lot 24217N0C0, 01/31/2026; Lot 24288N0C0, 04/30/2026; Lot 24331N0C0, 5/31/2026 - May 14, 2024 · Class II · American Regent, Inc.
Lack of Assurance of Sterility.
Lots: Lot #: 23087N0C0, Exp. Date 11/2024
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Nicardipine: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 2.5 mg per 1 mL
- Approval
- ANDA ANDA090534
- On the market since
- Oct 29, 2020
- Package NDCs
72572-470-0172572-470-10- Official label
- DailyMed (National Library of Medicine), updated May 1, 2020
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