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

Recall Number: D-0286-2019

Firm: Takeda Development Center Americas, Inc.

Classification: Class III

Status: Terminated

Report Date: 20181121

Initiation Date: 20181106

Termination Date: 20190620

Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.

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