Takeda Development Center Americas, Inc. recalls AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by: Sucampo Pharma Americas, LLC, Rockville MD
Recalled November 21, 2018 · FDA recall D-0286-2019 · Takeda Development Center Americas
Hazard
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing. · FDA Class III
Units
69,075 60-count bottles (4,144,500 capsules)
Sold at
Product was distributed to 32 distributors throughout the United States.
Description
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
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
Manufacturer(s)
Takeda Development Center Americas, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →