FDA-Drug2025-05-07Class II
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]
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
7,249 (cartons of 10 x 10 mL 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, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01]
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0399-2025Don't want to check this manually?
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