Recall: D-0503-2024

Class II - Potentially Harmful

Class IIClassification

2024-05-14Initiated

TerminatedStatus

American Regent, Inc.Firm

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.

Distribution

UT only

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.