Amitiza Capsule, Gelatin Coated
FDA Recall NDC 64764-080
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Amitiza (NDC 64764-080). A significant event, classified as Class II, was initiated on May 13, 2019 by Takeda Pharmaceuticals America, Inc.. The reported reason for this action was: "Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.
May 13, 2019
May 29, 2019
80,640 bottles
Recall Profile & Regulatory Data
Event ID
82830
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
MALLINCKRODT PHARMACEUTICALS
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide
Termination Date
Jul 17, 2023
Product Description
Amitiza (lubiprostone) capsules, 24 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-240-60
Batch or Lot Expiration Information
Lot# : 3200626-61, Exp 02/2022
Affected Packages Involved in this Recall
64764-080-60Product
64764-080-40Product
64764-240-60Product
64764-240-10Product
64764-240-40Product
Class II Terminated
Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.
May 13, 2019
May 29, 2019
89,808 bottles
Recall Profile & Regulatory Data
Event ID
82830
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
MALLINCKRODT PHARMACEUTICALS
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide
Termination Date
Jul 17, 2023
Product Description
Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-080-60
Batch or Lot Expiration Information
Lot# : 3229691-61, Exp 01/2022
Affected Packages Involved in this Recall
64764-080-60Product
64764-080-40Product
64764-240-60Product
64764-240-10Product
64764-240-40Product
November 2018 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
Nov 06, 2018
Nov 21, 2018
69,075 60-count bottles (4,144,500 capsules)
Recall Profile & Regulatory Data
Event ID
81518
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Takeda Development Center Americas, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to 32 distributors throughout the United States.
Termination Date
Jun 20, 2019
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
Batch or Lot Expiration Information
Lot# 3098628-61, exp. date 02/28/2021
Affected Packages Involved in this Recall
64764-080-60Product
64764-080-40Product
64764-240-60Product
64764-240-10Product
64764-240-40Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
