FDA recall D-0503-2024

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

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

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