Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

niCARdipine Hydrochloride Injection Recalled by American Regent, Inc. Due to Lack of Assurance of Sterility.

Date: May 14, 2024
Company: American Regent, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact American Regent, Inc. directly.

Affected Products

niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenous Use Only, Mfd for: Civica, Inc., Lehi, UT 84043; Mfd by: American Regent, Inc., New Albany, OH 43054. NDC 72572-470-10

Quantity: 4,136 cartons (10 vials in each carton)

Why Was This Recalled?

Lack of Assurance of Sterility.

Where Was This Sold?

This product was distributed to 1 state: UT

Affected (1 state)Not affected

About American Regent, Inc.

American Regent, Inc. has 7 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report