RecallRadar

FDA Drug recall D-901-2013

Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ for Abbott Laboratories,…

On 2013-08-28 the FDA classified a Class III recall of Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ for Abbott Laboratories,… by Abbvie, citing labeling: Incorrect Package Insert; product packaged with outdated version of the insert.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-901-2013
ClassificationClass III
Statusterminated
Initiated2013-08-01
Published2013-08-28
Last updated2026-09-13 11:51 UTC
CompanyAbbvie
DistributionUS

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

Labeling: Incorrect Package Insert; product packaged with outdated version of the insert

Identifiers

code_infoLot 22033GY

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-901-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.