February 2015 FDA Recall Drug by Mylan Institutional Llc
D-0412-2015 - Correct Labeled Product Mispack

This Class III drug recall was voluntarily initiated by Mylan Institutional Llc on February 11, 2015 for the product Drug. The FDA reported the reason for recall as correct labeled product mispack. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0412-2015

Reason for Recall
Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may have been mis-packaged in a carton labeled Doxorubicin Hydrochloride Injection 2 mg/mL, 100 mL
Initiated
02-11-2015
Reported
03-25-2015
Quantity
936 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70565
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-09-2016
Product Description About Product Description
Full technical description of the product.
DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL), For IV Use Only, Sterile, ISOTONIC SOLUTION, Caution: Cytotoxic Agent, 100 mL Multi-Dose Vial, Rx Only, Manufactured By: Onco Therapies Limited, Bangalore, 560105, INDIA, Distributed By: Amneal-Agila, LLC, Glasgow, KY, 42141, NDC 53150-317-01.

Batch or Lot Expiration Information

Lot# Lot Number: 7801009; Exp: Apr-2015