FDAHealthApril 18, 2025
American Regent, Inc. — 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 Via
⚠️ Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 18, 2025
Nationwide in the USA
What's affected?
- 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]
- Lot code
- s
Additional details
Lots, expiry: Lot 24086N0C0, 7/31/2025; Lot 24076N0C0, Lot 24090N0C0, 8/31/2025, Lot 25011N0C0, 6/30/2026;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 7,249 (cartons of 10 x 10 mL vials).
Get Health recall alerts
Delivered to your inbox. Free. No account required.