Recalls / Class II
Class IID-0399-2025
Product
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01]
- Brand name
- Nicardipine Hydrochloride
- Generic name
- Nicardipine Hydrochloride
- Active ingredient
- Nicardipine Hydrochloride
- Route
- Intravenous
- NDC
- 0517-0735
- FDA application
- ANDA090534
- Affected lot / code info
- Lots, expiry: Lot 24086N0C0, 7/31/2025; Lot 24076N0C0, Lot 24090N0C0, 8/31/2025, Lot 25011N0C0, 6/30/2026;
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.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 6610 New Albany Rd E, N/A, New Albany, Ohio 43054-8730
Distribution
- Quantity
- 7,249 (cartons of 10 x 10 mL 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-0399-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.