Class II
Ongoing
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.
This recall is currently active, issued May 7, 2025. It was issued by American Regent, Inc..
- Company
- American Regent, Inc.
- Recall Initiated
- April 18, 2025
- Posted
- May 7, 2025
- Recall Number
- D-0398-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 29,777 (cartons of 10 x 10mL vials)
- Firm Location
- New Albany, OH, United States
- Official Source
- View on FDA website ↗
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
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
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