Why it was recalled
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
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
Lot numbers, UPCs & expiration codes
Lot # 3098628-61, exp. date 02/28/2021
Where it was sold
Product was distributed to 32 distributors throughout the United States.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0286-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 6, 2018
- FDA report date
- Nov 21, 2018
- Quantity
- 69,075 60-count bottles (4,144,500 capsules)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Takeda Development Center Americas, Inc.
Original FDA data
Every field from FDA enforcement report D-0286-2019, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 81518
- Address
- 1 Takeda Pkwy
- Address (line 2)
- 4034BB1
- Code information
- Lot # 3098628-61, exp. date 02/28/2021
- Postal code
- 60015-5713
- Report date
- Nov 21, 2018
- Product type
- Drugs
- Recall number
- D-0286-2019
- Classification
- Class III
- Recalling firm
- Takeda Development Center Americas, Inc.
- Product quantity
- 69,075 60-count bottles (4,144,500 capsules)
- Termination date
- Jun 20, 2019
- Reason for recall
- Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed to 32 distributors throughout the United States.
- Recall initiation date
- Nov 6, 2018
- Initial firm notification
- Letter
- Center classification date
- Nov 28, 2018