FDA Drug recall D-0503-2024
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…
- FDA Drug
- Class II
- terminated
- Published 2024-05-29
On 2024-05-29 the FDA classified a Class II recall of 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… by American Regent, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0503-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-05-14 |
| Published | 2024-05-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | American Regent |
| Distribution | UT |
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
Lack of Assurance of Sterility.
Identifiers
| ndc | 72572-470-01 |
|---|---|
| ndc | 72572-470-10 |
| code_info | Lot #: 23087N0C0, Exp. Date 11/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0503-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.