Drug recall D-0286-2019
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.
Lots and codes
Lot # 3098628-61, exp. date 02/28/2021
Recall details
- Recalling firm
- Takeda Development Center Americas, Inc., Deerfield, IL
- Quantity
- 69,075 60-count bottles (4,144,500 capsules)
- Distribution
- Product was distributed to 32 distributors throughout the United States.
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 6, 2018
- Terminated
- June 20, 2019
Related products
- Amitiza – drug information
- NDC 64764-080 Amitiza · Lubiprostone 8 ug/1 · Takeda Pharmaceuticals America, Inc.
- NDC 64764-240 Amitiza · Lubiprostone 24 ug/1 · Takeda Pharmaceuticals America, Inc.