FDARecalled May 7, 2025 · #D-0399-2025
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]
Hazard
Class II — temporary health risk
Be the first to hear about future recalls.
Add the things you own to a watchlist. We’ll alert you the moment one matches.
Get started, freeDescription
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance. Classification: Class II Distribution: Nationwide in the USA
Product details
- 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]
- Type
- Drugs
- Manufacturer
- American Regent, Inc.
- Model numbers
- 24086N0C0, 24076N0C0, 24090N0C0, 25011N0C0
- UPCs
- —