Reported Oct 10, 2018 · Terminated
treatNOW ABILIFY (aripiprazole) / ABILIFY MAINTENA 400-mg (aripiprazole) 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) / 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 byOtsuka America Pharmaceutical, Inc. Rockville
- MD 20850 USA Marketed byLundbleck, Deerfield, IL 60015 USA Bar Code VialKit-59148-10Tabs-02
- Lot codes and dates
2 of 2 products · 4 lot codes
Recalled lot codes, grouped by product number Lots Lot codes and dates 7F92YUD3H1AACS1616BEXP 31-Jul-2019
F92YUD3H1AACS0118CEXP 30-Jun-2020
- Amount recalled
- 4738 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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