Multi-event April 2024 FDA Recall Abilify by Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
This Multi-event Class III drug recall was voluntarily initiated by Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. on April 9, 2024 for the product Abilify. The FDA reported the reason for recall as cross contamination with other products. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0466-2024
Cross Contamination with Other Products
04-09-2024
05-01-2024
108,192/30 count bottles or 7 count blister packs
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13
Batch or Lot Expiration Information
Lot# AKS00623A, Exp 01/31/2026; AKS00322A, Exp 02/28/2025
Affected Packages Involved in this Recall
Recall Number: D-0468-2024
Cross Contamination with Other Products
04-09-2024
05-01-2024
N/A
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13
Batch or Lot Expiration Information
Lot# AMS00223A, Exp 07/31/2025
Affected Packages Involved in this Recall
Recall Number: D-0467-2024
Cross Contamination with Other Products
04-09-2024
05-01-2024
N/A
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs (NDC 59148-008-95), RX only, Otsuka America Pharmaceutical, Inc.
Batch or Lot Expiration Information
Lot# : a) ALS00422A, Exp 04/30/2025; ALS00523A, Exp 11/30/2025; b) 1K77YUD1H1A, Exp 11/30/2024
Affected Packages Involved in this Recall
Recall Number: D-0469-2024
Cross Contamination with Other Products
04-09-2024
05-01-2024
N/A
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13
Batch or Lot Expiration Information
Lot# APS00423A, Exp 07/31/2025; APS00222A, Exp 11/30/2024
