February 2013 FDA Recall Drug by Mylan Pharmaceuticals Inc.
D-269-2013 - Tablets/Capsules Imprinted With Wrong ID

This Class III drug recall was voluntarily initiated by Mylan Pharmaceuticals Inc. on February 26, 2013 for the product Drug. The FDA reported the reason for recall as tablets/capsules imprinted with wrong id. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-269-2013

Reason for Recall
Tablets/Capsules Imprinted With Wrong ID: Pharmaceuticals are imprinted with an incorrect identifier code on the embossed tablets..
Initiated
02-26-2013
Reported
05-01-2013
Quantity
2,405 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64924
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 Pharmaceuticals Inc.
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.
12-05-2013
Product Description About Product Description
Full technical description of the product.
Lisinopril Tablets, USP 10 mg, Rx only, 1000 count bottles, Manufactured for: Mylan Pharmaceuticals Inc ,Morgantown, WV 26505 U.S.A. Made in India; NDC 0378-20740-10

Batch or Lot Expiration Information

Lot# 3002450; exp 8/14