← FDA ENFORCEMENT
D-0398-2025Class II

American Regent, Inc.

Recalling firm
American Regent, Inc.
Product type
Drug
Status
Ongoing
Report date
2025-05-07
Distribution
Nationwide in the USA
Firm state
OH
Product quantity
29,777 (cartons of 10 x 10mL vials)
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.

Product description

niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc., Lehi, UT 84043,Mfd by: American Regent, Inc., New Albany, OH 43064. NDC Carton: 72572-470-10/ NDC Vial: 72572-470-01.

Code / lot info

Lots, expiry: Lot 24025N0C0, 6/30/2025; Lot 24115N0C0, 10/31/2025; Lot 24116N0C0, 3/31/2026; Lot 24160N0C0, 12/31/2025; Lot 24217N0C0, 01/31/2026; Lot 24288N0C0, 04/30/2026; Lot 24331N0C0, 5/31/2026

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.