Recalls / Class III

Class IIID-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

Affected lot / code info

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

Why it was recalled

Subpotent Drug and Failed Impurities/Degradation Specifications

Recalling firm

Firm

Mylan Institutional LLC

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

4901 Hiawatha Dr, Rockford, Illinois 61103-1287

Distribution

Quantity

78,090 vials

Distribution pattern

Nationwide

Timeline

Recall initiated

2015-01-23

FDA classified

2015-03-16

Posted by FDA

2015-03-25

Terminated

2016-04-11

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0413-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.