Drug recall D-0503-2024

Class II Terminated reported May 29, 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.

Lots and codes

Lot #: 23087N0C0, Exp. Date 11/2024

Recall details

Recalling firm
American Regent, Inc., New Albany, OH
Quantity
4,136 cartons (10 vials in each carton)
Distribution
UT only
Type
Voluntary: Firm initiated
Recall initiated
May 14, 2024
Terminated
December 23, 2025

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