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
Reported: November 21, 2018 Initiated: November 6, 2018 #D-0286-2019
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
Reason for Recall
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
Details
- Recalling Firm
- Takeda Development Center Americas, Inc.
- Units Affected
- 69,075 60-count bottles (4,144,500 capsules)
- Distribution
- Product was distributed to 32 distributors throughout the United States.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Takeda Development Center Americas, Inc.. Units affected: 69,075 60-count bottles (4,144,500 capsules).
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 21, 2018. Severity: Low. Recall number: D-0286-2019.
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