Drug Enforcement D-498-2013

Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label

Status

Terminated

Classification

Class III

Report Date

June 5, 2013

Termination Date

January 23, 2014

Product Information

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
Product quantity
1776 bottles
Reason for recall
Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Aurobindo Pharma USA Inc
Address
666 Plainsboro Rd. Suite 210, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-498-2013
Event ID
65071
Recall initiation date
April 9, 2013
Center classification date
May 30, 2013
Code info
Lot KP3012001-A Exp.12/13 Lot KP3012002-A Exp.12/13
More code info
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