# FDA recall D-0503-2024

> **American Regent, Inc.** · Class II · drug recall initiated 2024-05-14.

## 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

## Reason for recall

Lack of Assurance of Sterility.

## Distribution

UT only

## Key facts

- **Recall number:** D-0503-2024
- **Recalling firm:** American Regent, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-05-14
- **Report date:** 2024-05-29
- **Termination date:** 2025-12-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** New Albany, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0503-2024

## Citation

> AI Analytics. FDA recall D-0503-2024. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/D-0503-2024. Source: US FDA. Licensed CC0.

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