Drug recall
AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by: Sucampo Pharma Americas, LLC…
FDA recall event 81518 · Class III · Takeda Development Center Americas, Inc.
Key facts
| Event ID | 81518 |
|---|---|
| Recall numbers | D-0286-2019 |
| Recalling firm | Takeda Development Center Americas, Inc. |
| Product type | Drugs |
| Products | 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… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing. |
| Initiation date | Nov 6, 2018 |
| Report date | Nov 21, 2018 |
| Termination date | Jun 20, 2019 |
| City | Deerfield |
| State | IL |
| Country | United States |
| FEI number | 3002393210 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: