FDA-Drug2025-05-07Class II
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.
American Regent, Inc.
Hazard
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Sold states
Nationwide in the USA
Affected count
29,777 (cartons of 10 x 10mL vials)
Manufactured in
6610 New Albany Rd E, N/A, New Albany, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0398-2025Don't want to check this manually?
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