Amitiza recall: Impurity Out of Spec
AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by: Sucampo Pharma Americas, LLC, Rockville MD 20850 and Takeda…
Why was Amitiza recalled?
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 3098628-61, exp. date 02/28/2021
- Product
- AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by: Sucampo Pharma Americas, LLC, Rockville MD 20850 and Takeda…
- Recalling firm
- Takeda Development Center Americas, Inc.
- Quantity
- 69,075 60-count bottles (4,144,500 capsules)
- Distribution
- Product was distributed to 32 distributors throughout the United States.
- Recall date
- November 21, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)