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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Product Detail

Product Description 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
Recall Number D-498-2013
Classification Class III
Code Info Lot KP3012001-A Exp.12/13 Lot KP3012002-A Exp.12/13
Product Distributed Qty 1776 bottles
Reason For Recall Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label

Event Detail

Event Id 65071
Product Type Drugs
Status Ongoing
Recalling Firm Aurobindo Pharma USA Inc
City Plainsboro
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-09
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide