Otsuka Pharmaceutical Development & Commercialization, Inc. recalls treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA (aripiprazole) 400MG for extended release injectable suspension. Ki
Recalled October 10, 2018 · FDA recall D-0017-2019 · Otsuka Pharmaceutical Development & Commercialization
Hazard
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. · FDA Class III
Units
17325 kits
Sold at
Nationwide in the US
Description
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.
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
Manufacturer(s)
Otsuka Pharmaceutical Development & Commercialization, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →