Status
Ongoing
Drug Enforcement D-0399-2025
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, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01]
- Product quantity
- 7,249 (cartons of 10 x 10 mL 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-0399-2025
- Event ID
- 96695
- Recall initiation date
- April 18, 2025
- Center classification date
- May 1, 2025
- Code info
- Lots, expiry: Lot 24086N0C0, 7/31/2025; Lot 24076N0C0, Lot 24090N0C0, 8/31/2025, Lot 25011N0C0, 6/30/2026;
- More code info
- —