Mylan Institutional LLC recalls Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for…

Recall date

January 23, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0413-2015

FDA classification

Class III

Brand / firm

Mylan Institutional LLC

Sold / distributed

Nationwide

Why it was recalled

Subpotent Drug and Failed Impurities/Degradation Specifications

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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