FDA recall D-901-2013

Product

Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ for Abbott Laboratories, North Chicago, IL 60064, USA

Reason for recall

Labeling: Incorrect Package Insert; product packaged with outdated version of the insert

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-08-01

Report date

2013-08-28

Termination date

2013-11-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Chicago, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-901-2013