Status
Ongoing
Drug Enforcement D-0398-2025
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Classification
Class II
Report Date
May 7, 2025
Termination Date
—
Product Information
- Product description
- 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.
- Product quantity
- 29,777 (cartons of 10 x 10mL vials)
- Reason for recall
- Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- American Regent, Inc.
- Address
-
6610 New Albany Rd E, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0398-2025
- Event ID
- 96695
- Recall initiation date
- April 18, 2025
- Center classification date
- May 1, 2025
- 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
- More code info
- —