Otsuka Recalls Mislabeled treatNOW Abilify Physician Sample Kits
Otsuka is recalling 17,325 treatNOW Abilify physician sample kits 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, and the issue is limited to labeling errors.
Plain-English summary
Otsuka Pharmaceutical Development & Commercialization, Inc. is recalling 17,325 kits of treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA (aripiprazole) 400MG for extended release injectable suspension. The affected kits contain 2 packs of ABILIFY Tablets 10mg (14-day supply) and 1 ABILIFY MAINTENA Pre-filled Dual Chamber Syringe Kit. The recall covers lots 7F92YUD3H1A/AIS1017B and 7F92YUD3H1A/AIS1017C with an expiration date of 30-Jun-2020.
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 affected kits were distributed nationwide in the US. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers and healthcare providers should stop using the affected kits and contact Otsuka for further instructions.
The recalled product
- Product
- 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.…
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 17,325
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 (3)
- Lots: 7F92YUD3H1A/AIS1017B
- 7F92YUD3H1A/AIS1017C
- 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 →Related recalls
Same manufacturer · Otsuka Pharmaceutical Development & Commercialization, Inc.
See all →- LowOtsuka Recalls Mislabeled Abilify and Abilify Maintena Physician Sample Kits
FDA (Drugs) · 2018-10-10
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