FDAFDA · Food and drugs·Recall number D-0399-2025
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]
Published May 7, 2025 · Recall initiated: April 18, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- NICARDIPINE HYDROCHLORIDE
- Manufacturer
- American Regent, Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lots, expiry: Lot 24086N0C0, 7/31/2025; Lot 24076N0C0, Lot 24090N0C0, 8/31/2025, Lot 25011N0C0, 6/30/2026;
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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