Reported Oct 10, 2018 · Terminated
treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA (aripiprazole) 400MG for extended release injectable suspension.…
Otsuka Pharmaceutical Development & Commercialization, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Otsuka Pharmaceutical Development & Commercialization, Inc. · 508 Carnegie Ctr · Princeton, NJ · 08540-6259
Is this the product you have?
- treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA (aripiprazole) 400MG for extended release injectable suspension
- Kit Contents2 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 byOtsuka America Pharmaceutical, Inc. Rockville, MD 20850
- Marketed byDeerfield, IL 60015 USA. Bar Code DCSKit-59148-10Tabs-01
- Lot codes and dates
- Lots
7F92YUD3H1A/AIS1017B7F92YUD3H1A/AIS1017CEXP 30-Jun-2020
- Lots
- Amount recalled
- 17325 kits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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