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.
Product description
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
Lot numbers, UPCs & expiration codes
Lots: 7F92YUD3H1A/AIS1017B, 7F92YUD3H1A/AIS1017C, EXP 30-Jun-2020.
Where it was sold
Nationwide in the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0017-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 17, 2018
- FDA report date
- Oct 10, 2018
- Quantity
- 17325 kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Original FDA data
Every field from FDA enforcement report D-0017-2019, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 81020
- Address
- 508 Carnegie Ctr
- Code information
- Lots: 7F92YUD3H1A/AIS1017B, 7F92YUD3H1A/AIS1017C, EXP 30-Jun-2020.
- Postal code
- 08540-6259
- Report date
- Oct 10, 2018
- Product type
- Drugs
- Recall number
- D-0017-2019
- Classification
- Class III
- Recalling firm
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Product quantity
- 17325 kits
- Termination date
- Mar 9, 2022
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Sep 17, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 12, 2018