D-0018-2019 Class III Terminated
FDA drug recall D-0018-2019 was initiated by Otsuka Pharmaceutical Development & Commercialization, Inc. on September 17, 2018 and is designated Class III. Reason for recall: 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 incorrectl… The recall status is terminated (terminated March 9, 2022). Affected quantity: 4738 kits.
Recall Details
- Product Type
- Drugs
- Report Date
- October 10, 2018
- Initiation Date
- September 17, 2018
- Termination Date
- March 9, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4738 kits
Product 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
Reason for Recall
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.
Distribution Pattern
Nationwide in the US
Code Information
Lots: 7F92YUD3H1A/ACS1616B, EXP 31-Jul-2019; F92YUD3H1A/ACS0118C, EXP 30-Jun-2020.