Drug recall D-0413-2015

Class III Terminated reported Mar 25, 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

Lots and codes

Lot #: UW301, UW302, Exp 02/15; UW303, UW304, UW305, UW306, Exp 04/15

Recall details

Recalling firm
Mylan Institutional LLC, Rockford, IL
Quantity
78,090 vials
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
January 23, 2015
Terminated
April 11, 2016