Takeda Development Center Americas, Inc. recalls AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by: Sucampo Pharma Americas, LLC, Rockville M…
- Recall date
- November 6, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0286-2019
- FDA classification
- Class III
- Brand / firm
- Takeda Development Center Americas, Inc.
- Sold / distributed
- Product was distributed to 32 distributors throughout the United States.
Why it was recalled
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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