May 2024 FDA Recall Nicardipine Hydrochloride by American Regent, Inc.
D-0503-2024 - Lack of Assurance of Sterility.
This Class II drug recall was voluntarily initiated by American Regent, Inc. on May 14, 2024 for the product Nicardipine Hydrochloride. The FDA reported the reason for recall as lack of assurance of sterility.. The product was distributed in UT only and the recall is currently terminated.
Recall Number: D-0503-2024
Lack of Assurance of Sterility.
05-14-2024
05-29-2024
4,136 cartons (10 vials in each carton)
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
American Regent, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
UT only
12-23-2025
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# : 23087N0C0, Exp. Date 11/2024
