Otsuka Pharmaceutical Development & Commercialization product recalled over labeling errors

Recall date

September 17, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Otsuka Pharmaceutical Development & Commercialization, Inc. recalls treatNOW ABILIFY (aripiprazole) / ABILIFY MAINTENA 400-mg (aripiprazole) for extended release injectable suspension. Ki…

Recall number

D-0018-2019

FDA classification

Class III

Brand / firm

Otsuka Pharmaceutical Development & Commercialization, Inc.

Sold / distributed

Nationwide in the US

Why it was recalled

Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions are missing and contents of kits may be incorrectly labeled on the outer packaging of the co-packaged kit.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

treatNOW ABILIFY (aripiprazole) / ABILIFY MAINTENA 400-mg (aripiprazole) for extended release injectable suspension. Kit contents 2 packs Abilify Tablets 10 mg (14 day supply) plus 1 Abilfy Maintena Vial Kit.Rx only. Distributed and Marketed by: Otsuka America Pharmaceutical, Inc. Rockville, MD 20850 USA Marketed by: Lundbleck, Deerfield, IL 60015 USA Bar Code VialKit-59148-10Tabs-02