🔍 RecallPedia

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

Class I - Dangerous
💊 Drugs Recalled: November 6, 2018 Takeda Development Center Americas Prescription Drugs

What Should You Do?

  1. Check if you have this product:
    Lot # 3098628-61, exp. date 02/28/2021
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Takeda Development Center Americas, Inc.
Reason for Recall:
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0286-2019

Related Recalls