Class IIReported 2025-05-07
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]
Recalled by American Regent, Inc.
Reason for Recall
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
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Recall NumberD-0399-2025ClassificationClass IIStatusOngoingCategorydrugInitiated2025-04-18Reported2025-05-07DistributionNationwide in the USACode InfoLots, expiry: Lot 24086N0C0, 7/31/2025; Lot 24076N0C0, Lot 24090N0C0, 8/31/2025, Lot 25011N0C0, 6/30/2026;Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.