Recalls / Class II
Class IID-0398-2025
Product
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc., Lehi, UT 84043,Mfd by: American Regent, Inc., New Albany, OH 43064. NDC Carton: 72572-470-10/ NDC Vial: 72572-470-01.
- Brand name
- Nicardipine Hydrochloride
- Generic name
- Nicardipine Hydrochloride
- Active ingredient
- Nicardipine Hydrochloride
- Route
- Intravenous
- NDC
- 72572-470
- FDA application
- ANDA090534
- Affected lot / code info
- 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
Why it was recalled
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Recalling firm
- Firm
- American Regent, Inc.
- Manufacturer
- Civica, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 6610 New Albany Rd E, N/A, New Albany, Ohio 43054-8730
Distribution
- Quantity
- 29,777 (cartons of 10 x 10mL vials)
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-04-18
- FDA classified
- 2025-05-01
- Posted by FDA
- 2025-05-07
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0398-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.