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
7,249 (cartons of 10 x 10 mL vials)
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental MonitoringReason 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, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01]
Code / lot info
Lots, expiry: Lot 24086N0C0, 7/31/2025; Lot 24076N0C0, Lot 24090N0C0, 8/31/2025, Lot 25011N0C0, 6/30/2026;
Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →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.