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niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, ...

FDA Recall #D-0503-2024 — Class II — May 14, 2024

Recall #D-0503-2024 Date: May 14, 2024 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

Lack of Assurance of Sterility.

Recalling Firm

American Regent, Inc. — New Albany, OH

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

4,136 cartons (10 vials in each carton)

Distribution

UT only

Code Information

Lot #: 23087N0C0, Exp. Date 11/2024

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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