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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Product Detail

Product Description MavikĀ® trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ for Abbott Laboratories, North Chicago, IL 60064, USA
Recall Number D-901-2013
Classification Class III
Code Info Lot 22033GY
Product Distributed Qty 704 bottles
Reason For Recall Labeling: Incorrect Package Insert; product packaged with outdated version of the insert

Event Detail

Event Id 65851
Product Type Drugs
Status Ongoing
Recalling Firm AbbVie Inc.
City North Chicago
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-01
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide