D-0286-2019 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 21, 2018
- Initiation Date
- November 6, 2018
- Termination Date
- June 20, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 69,075 60-count bottles (4,144,500 capsules)
Product Description
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.
Distribution Pattern
Product was distributed to 32 distributors throughout the United States.
Code Information
Lot # 3098628-61, exp. date 02/28/2021