April 2013 FDA Recall Drug by Aurobindo Pharma Usa Inc
D-498-2013 - Labeling
This Class III drug recall was voluntarily initiated by Aurobindo Pharma Usa Inc on April 9, 2013 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-498-2013
Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label
04-09-2013
06-05-2013
1776 bottles
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.
Aurobindo Pharma USA Inc
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
01-23-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufactured for: Aurobindo Pharma USA Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad- 500 072 India
Batch or Lot Expiration Information
Lot# Lot KP3012001-A Exp.12/13 Lot KP3012002-A Exp.12/13
