November 2018 FDA Recall Amitiza by Takeda Development Center Americas, Inc.
D-0286-2019 - Failed Impurities/Degradation Specifications
This Class III drug recall was voluntarily initiated by Takeda Development Center Americas, Inc. on November 6, 2018 for the product Amitiza. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed in Product was distributed to 32 distributors throughout the United States. and the recall is currently terminated.
Recall Number: D-0286-2019
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
11-06-2018
11-21-2018
69,075 60-count bottles (4,144,500 capsules)
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Takeda Development Center Americas, Inc.
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.
Product was distributed to 32 distributors throughout the United States.
06-20-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by: Sucampo Pharma Americas, LLC, Rockville MD 20850 and Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015. Active Ingredient made in Japan, encapsulated in the United States. NDC 64764-080-60
Batch or Lot Expiration Information
Lot# 3098628-61, exp. date 02/28/2021
