FDARecalled May 7, 2025 · #D-0398-2025
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 Ca...
Hazard
Class II — temporary health risk
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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, 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.
- Type
- Drugs
- Manufacturer
- American Regent, Inc.
- Model numbers
- 24025N0C0, 24115N0C0, 24116N0C0, 24160N0C0, 24217N0C0, 24288N0C0, 24331N0C0
- UPCs
- —