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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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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
Distribution Pattern Nationwide

Product Detail

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