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) and ABILIFY MAINTENA (aripiprazole) 400MG for extended release injectable suspension. K…

Recall number

D-0017-2019

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) and ABILIFY MAINTENA (aripiprazole) 400MG for extended release injectable suspension. Kit Contents: 2 packs ABILIFY Tablets 10mg (14 day supply) plus 1 ABILIFY MAINTENA Pre-filled Dual Chamber Syringe Kit. Rx only. Not for sale or reimbursement. Distributed and Marketed by: Otsuka America Pharmaceutical, Inc. Rockville, MD 20850. Marketed by: Deerfield, IL 60015 USA. Bar Code DCSKit-59148-10Tabs-01