American Regent, Inc.: 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 Alba

Hazard

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.

Details from the source

Reason for recall: Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance. Distribution: Nationwide in the USA Quantity: 29,777 (cartons of 10 x 10mL vials) Lot/code info: Lots, expiry: Lot 24025N0C0, 6/30/2025; Lot 24115N0C0, 10/31/2025; Lot 24116N0C0, 3/31/2026; Lot 24160N0C0, 12/31/2025; Lot 24217N0C0, 01/31/2026; Lot 24288N0C0, 04/30/2026; Lot 24331N0C0, 5/31/2026

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.