Drug Recall: 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 Carto
American Regent, Inc. · April 18, 2025
Reason for Recall
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Product Description
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.
Distribution
Nationwide in the USA
States Affected
NATIONWIDE
Quantity Affected
29,777 (cartons of 10 x 10mL vials)
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0398-2025
Status: ongoing
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