NICARDIPINE HYDROCHLORIDE

Generic: NICARDIPINE HYDROCHLORIDE

Eugia US LLCManufacturer

INTRAVENOUSRoute

NICARDIPINE HYDROCHLORIDEActive Substance

2021-04-08Original Approval

NICARDIPINE HYDROCHLORIDE is FDA application ANDA211121, sponsored by EUGIA PHARMA. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2024-02-20

Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedics Pharma LLC 279 Prin

Failed Impurities/Degradation Specifications: Out of specification for organic impurities

Class II2024-02-20

Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMedics Pharm

Failed Impurities/Degradation Specifications: Out of specification for organic impurities

Class II2025-04-18

niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc

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

Class II2026-07-24

niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dose Vial (NDC 72572-470-0

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, gla

Class II2025-04-18

niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc

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

Class II2024-05-14

niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenou

Lack of Assurance of Sterility.

Class III2013-05-13

Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Scien

Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpurid

NICARDIPINE HYDROCHLORIDE

Recalls

Top Reported Reactions