Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-224-10

Recall Number: D-0413-2015

Firm: Mylan Institutional LLC

Classification: Class III

Status: Terminated

Report Date: 20150325

Initiation Date: 20150123

Termination Date: 20160411

Subpotent Drug and Failed Impurities/Degradation Specifications

Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-224-10