Reported Nov 21, 2018 · Terminated
AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by: Sucampo Pharma Americas, LLC, Rockville…
Takeda Development Center Americas, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Takeda Development Center Americas, Inc. · 1 Takeda Pkwy · Deerfield, IL · 60015-5713
Is this the product you have?
- AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only
- Marketed bySucampo 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
- Lot codes and dates
Lot # 3098628-61exp. date 02/28/2021
- Amount recalled
- 69,075 60-count bottles (4,144,500 capsules)
Why it was recalled
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Takeda Development Center Americas, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.