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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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Description

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