FDA-Drug2015-03-25Class III

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

Mylan Institutional LLC
Hazard

Subpotent Drug and Failed Impurities/Degradation Specifications

Sold states
Nationwide
Affected count
78,090 vials
Manufactured in
4901 Hiawatha Dr, Rockford, IL, United States
Products
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

Official notice

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

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