FDA recall D-0413-2015

Product

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

Reason for recall

Subpotent Drug and Failed Impurities/Degradation Specifications

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-01-23

Report date

2015-03-25

Termination date

2016-04-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rockford, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0413-2015