Drug Enforcement D-901-2013

Labeling: Incorrect Package Insert; product packaged with outdated version of the insert

Status

Terminated

Classification

Class III

Report Date

August 28, 2013

Termination Date

November 7, 2013

Product Information

Product description
Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ for Abbott Laboratories, North Chicago, IL 60064, USA
Product quantity
704 bottles
Reason for recall
Labeling: Incorrect Package Insert; product packaged with outdated version of the insert
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
AbbVie Inc.
Address
1401 Sheridan Rd, N/A

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

Codes & Dates

Recall number
D-901-2013
Event ID
65851
Recall initiation date
August 1, 2013
Center classification date
August 20, 2013
Code info
Lot 22033GY
More code info
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