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

FDA recall notice · announced March 25, 2015 · Mylan Institutional

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Notes

Distribution: Nationwide
Lot/code information: Lot #: UW301, UW302, Exp 02/15; UW303, UW304, UW305, UW306, Exp 04/15
Quantity: 78,090 vials
Status: Terminated
Products in this recall event:
- 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 (D-0413-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.