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

FDA recall notice · announced November 21, 2018 · Takeda Development Center Americas

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

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

Reason for recall

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

Notes

Distribution: Product was distributed to 32 distributors throughout the United States.
Lot/code information: Lot # 3098628-61, exp. date 02/28/2021
Quantity: 69,075 60-count bottles (4,144,500 capsules)
Status: Terminated
Products in this recall event:
- 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 Ingr (D-0286-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.