Drug 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
D-0286-2019
Product summary
- Event
- Event 81518
- Status
- Terminated
- Classification
- Class III
- Quantity
- 69,075 60-count bottles (4,144,500 capsules)
- Official record key
drug-enforcement:D-0286-2019
Official wording
Reason: Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
Code information: Lot # 3098628-61, exp. date 02/28/2021
Distribution pattern: Product was distributed to 32 distributors throughout the United States.
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications