FDAFDA · Food and drugs·Recall number D-0286-2019
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
Published November 21, 2018 · Recall initiated: November 6, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- AMITIZA
- Manufacturer
- Takeda Development Center Americas, Inc.
- Distributor
- Product was distributed to 32 distributors throughout the United States.
- Lot
- Lot # 3098628-61, exp. date 02/28/2021
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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