Drug 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. Rockville, MD 20850 USA Marketed by: Lundbleck, Deerfield, IL 60015 USA Bar Code VialKit-59148-10Tabs-02
D-0018-2019
Product summary
- Event
- Event 81020
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4738 kits
- Official record key
drug-enforcement:D-0018-2019
Official wording
Reason: 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.
Code information: Lots: 7F92YUD3H1A/ACS1616B, EXP 31-Jul-2019; F92YUD3H1A/ACS0118C, EXP 30-Jun-2020.
Distribution pattern: Nationwide in the US
Derived failure modes
-
Labeling or packaging
mislabeled