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
Reason for recall: Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
Recall initiated: 20181106
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated