Class II
Drug Recall: 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.
American Regent, Inc. · May 14, 2024
Reason for Recall
Lack of Assurance of Sterility.
Product Description
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
Distribution
UT only
States Affected
UT
Quantity Affected
4,136 cartons (10 vials in each carton)
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0503-2024
Status: terminated
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