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AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by: Sucampo Pharma Amer...

FDA Recall #D-0286-2019 — Class III — November 6, 2018

Recall #D-0286-2019 Date: November 6, 2018 Classification: Class III Status: Terminated

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.

Recalling Firm

Takeda Development Center Americas, Inc. — Deerfield, IL

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

69,075 60-count bottles (4,144,500 capsules)

Distribution

Product was distributed to 32 distributors throughout the United States.

Code Information

Lot # 3098628-61, exp. date 02/28/2021

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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