Drug recall D-0398-2025
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.
Reason for recall
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Lots and codes
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
Recall details
- Recalling firm
- American Regent, Inc., New Albany, OH
- Quantity
- 29,777 (cartons of 10 x 10mL vials)
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 18, 2025
Related products
- Nicardipine Hydrochloride – drug information
- NDC 72572-470 Nicardipine Hydrochloride · Nicardipine Hydrochloride 2.5 mg/mL · Civica, Inc.