FDA-Drug2024-05-29Class II
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
American Regent, Inc.
Hazard
Lack of Assurance of Sterility.
Sold states
UT only
Affected count
4,136 cartons (10 vials in each carton)
Manufactured in
6610 New Albany Rd E, New Albany, OH, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0503-2024Don't want to check this manually?
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