Question 1

Is 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



 recalled?

Accepted Answer

Otsuka Pharmaceutical Development & Commercialization, Inc. is recalling 22,063 physician sample kits of treatNOW Abilify (aripiprazole) and Abilify Maintena (aripiprazole) due to significant labeling errors. The product name is misspelled on the packaging, critical storage instructions are missing, and the contents of the kits may be incorrectly identified on the outer carton. These kits were distributed nationwide across the United States as physician samples and are marked as 'not for sale.'

Question 2

What should I do?

Accepted Answer

Check your physician sample kit for the name 'treatNOW ABILIFY' or 'treatNOW ABILIFY / ABILIFY MAINTENA 400-mg' and look for barcodes DCSKit-59148-10Tabs-01 or VialKit-59148-10Tabs-02. For Pre-filled Dual Chamber Syringe Kits (Recall D-0017-2019), check for lot numbers 7F92YUD3H1A/AIS1017B or 7F92YUD3H1A/AIS1017C with an expiration date of 30-Jun-2020. For Vial Kits (Recall D-0018-2019), check for lot numbers 7F92YUD3H1A/ACS1616B (Exp 31-Jul-2019) or F92YUD3H1A/ACS0118C (Exp 30-Jun-2020). Contact your healthcare provider or pharmacist immediately for guidance if you have one of these mislabeled kits. Return any unused physician sample kits to the clinic or pharmacy where they were received for a refund or replacement instructions. Contact Otsuka Pharmaceutical at their Princeton, New Jersey headquarters for further information regarding this voluntary recall. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance or to report any adverse effects.

Question 3

How do I get a refund or replacement?

Accepted Answer

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Otsuka Pharmaceutical Development & Commercialization, Inc.: treatNOW Abilify Physician Sample Kits Recalled for Mislabeling

Summary

Risk

What You Should Do

Your Remedy Options

Affected Products

Additional Information