Recall D-0018-2019
Description: 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
Recall D-0018-2019 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0018-2019 |
| Event ID | 81020 |
| Distribution | Nationwide in the US |
| Quantity | 4738 kits |
| Recall 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. |
| Drug Classification | Class III |
| Drug Code Info | 20181010 |
| Recall Initiation Date | 20180917 |
| Report Date | 20181010 |
| Classification Date | 20181012 |
| Address | 508 Carnegie Ctr Princeton, NJ 08540-6259 United States |
| Recalling Firm | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| Initial Notification | Letter |
| Similar To |