Reported May 7, 2025 · Ongoing
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica,…
American Regent, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Regent, Inc. · 6610 New Albany Rd E · New Albany, OH · 43054-8730
Is this the product you have?
- niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only
- Mfd forCivica, Inc., Lehi, UT 84043
- Mfd byAmerican Regent, Inc., New Albany, OH 43064
- NDC Carton72572-470-10/
- NDC Vial72572-470-01
- Lot codes and dates
- Lots
- expiry
Lot 24025N0C06/30/2025Lot 24115N0C010/31/2025Lot 24116N0C03/31/2026Lot 24160N0C012/31/2025Lot 24217N0C001/31/2026Lot 24288N0C004/30/2026Lot 24331N0C05/31/2026
- Amount recalled
- 29,777 (cartons of 10 x 10mL vials)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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