Class III
Terminated
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
- Recall Initiated
- September 17, 2018
- Posted
- October 10, 2018
- Recall Number
- D-0017-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 17325 kits
- Firm Location
- Princeton, NJ, United States
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
Nationwide in the US
Lot / Code Info
Lots: 7F92YUD3H1A/AIS1017B, 7F92YUD3H1A/AIS1017C, EXP 30-Jun-2020.
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