Agency classClass IIIOur severity:Low FDA (Drugs)·D-0018-2019·Announced 2018-10-10

Otsuka Recalls Mislabeled Abilify and Abilify Maintena Physician Sample Kits

Otsuka is recalling 4,738 physician sample kits of Abilify and Abilify Maintena due to labeling errors, including misspelled product names and missing storage instructions.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issues are limited to labeling errors such as misspelling and missing storage instructions.

Plain-English summary

Otsuka Pharmaceutical Development & Commercialization, Inc. is recalling 4,738 physician sample kits of treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA 400-mg for extended release injectable suspension. The kits contain two packs of Abilify Tablets 10 mg (14-day supply) and one Abilify Maintena Vial Kit. The affected lots are 7F92YUD3H1A/ACS1616B (EXP 31-Jul-2019) and F92YUD3H1A/ACS0118C (EXP 30-Jun-2020). The product was distributed nationwide in the US.

The recall was initiated because the physician sample kits are mislabeled. Specifically, the product name is misspelled, storage instructions are missing, and the contents of the kits may be incorrectly labeled on the outer packaging of the co-packaged kit. The FDA has classified this as a Class III recall, indicating that the labeling errors are unlikely to cause adverse health consequences.

Physicians and healthcare providers who have received these sample kits should stop using them and contact Otsuka for instructions on how to return the product. Patients who have already received prescriptions from these kits should consult their healthcare provider for guidance on their medication.

The recalled product

Product: 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 by: Otsuka America Pharmaceutical…
Manufacturer: Otsuka Pharmaceutical Development & Commercialization, Inc.
Category: Drug — Antipsychotic
Hazard: mis-labeling
Affected units: 4,738

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

Lots: 7F92YUD3H1A/ACS1616B
EXP 31-Jul-2019
F92YUD3H1A/ACS0118C
EXP 30-Jun-2020.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Otsuka Pharmaceutical Development & Commercialization, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Otsuka Pharmaceutical Development & Commercialization, Inc.

See all →

Low
Otsuka Recalls Mislabeled treatNOW Abilify Physician Sample Kits
FDA (Drugs) · 2018-10-10

Same hazard · mis labeling