January 2015 FDA Recall Drug by Mylan Institutional Llc
D-0413-2015 - Subpotent Drug and Failed Impurities/Degradation Specifications
This Class III drug recall was voluntarily initiated by Mylan Institutional Llc on January 23, 2015 for the product Drug. The FDA reported the reason for recall as subpotent drug and failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0413-2015
Subpotent Drug and Failed Impurities/Degradation Specifications
01-23-2015
03-25-2015
78,090 vials
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Mylan Institutional LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
04-11-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of 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
Batch or Lot Expiration Information
Lot# : UW301, UW302, Exp 02/15; UW303, UW304, UW305, UW306, Exp 04/15
