Recall record at a glance
| Official record | D-0286-2019 |
|---|---|
| Category | Drug Recalls |
| Classification | Class III |
| FDA record status | Terminated |
| Recalling firm | Takeda Development Center Americas, Inc. |
| Report date | Nov 21, 2018 |
| Recall initiation date | Nov 6, 2018 |
| Quantity | 69,075 60-count bottles (4,144,500 capsules) |
| Location | Deerfield, IL, United States |
Official 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
Why the product was recalled
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
Distribution information
Product was distributed to 32 distributors throughout the United States.
How to read the classification
FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.