FDA recall D-0286-2019

Takeda Development Center Americas, Inc. · Class III · 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

Reason for recall

Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.

Distribution

Product was distributed to 32 distributors throughout the United States.

Key facts

Status: Terminated
Initiation date: 2018-11-06
Report date: 2018-11-21
Termination date: 2019-06-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0286-2019