Drug 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. Distributed and Marketed by: Otsuka America Pharmaceutical, Inc. Rockville, MD 20850. Marketed by: Deerfield, IL 60015 USA. Bar Code DCSKit-59148-10Tabs-01
D-0017-2019
Product summary
- Event
- Event 81020
- Status
- Terminated
- Classification
- Class III
- Quantity
- 17325 kits
- Official record key
drug-enforcement:D-0017-2019
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/AIS1017B, 7F92YUD3H1A/AIS1017C, EXP 30-Jun-2020.
Distribution pattern: Nationwide in the US
Derived failure modes
-
Labeling or packaging
mislabeled