Recalls / Class III
Class IIID-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
- Brand name
- Amitiza
- Generic name
- Lubiprostone
- Active ingredient
- Lubiprostone
- Route
- Oral
- NDCs
- 64764-080, 64764-240
- FDA application
- NDA021908
- Affected lot / code info
- Lot # 3098628-61, exp. date 02/28/2021
Why it was recalled
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
Recalling firm
- Firm
- Takeda Development Center Americas, Inc.
- Manufacturer
- Takeda Pharmaceuticals America, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Takeda Pkwy, 4034BB1, Deerfield, Illinois 60015-5713
Distribution
- Quantity
- 69,075 60-count bottles (4,144,500 capsules)
- Distribution pattern
- Product was distributed to 32 distributors throughout the United States.
Timeline
- Recall initiated
- 2018-11-06
- FDA classified
- 2018-11-28
- Posted by FDA
- 2018-11-21
- Terminated
- 2019-06-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0286-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.