The Recall Desk

FDA (Drugs) recall action 81020

Otsuka Pharmaceutical Development & Commercialization, Inc. recalled 2 products on 2018-10-10

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2018-10-10
Critical
0
Units
22,063

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • LowFDA (Drugs)··2018-10-10

    Otsuka Recalls Mislabeled treatNOW Abilify Physician Sample Kits

    Otsuka is recalling 17,325 treatNOW Abilify physician sample kits due to labeling errors, including misspelled product names and missing storage instructions.

    Product
    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. Di
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2018-10-10

    Otsuka Recalls Mislabeled Abilify and Abilify Maintena Physician Sample Kits

    Otsuka is recalling 4,738 physician sample kits of Abilify and Abilify Maintena due to labeling errors, including misspelled product names and missing storage instructions.

    Product
    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
    Category
    Distribution
    0 states