Amitiza 8 ug capsule, gelatin coated

Where it's made

This label doesn't name the factory that makes the drug. Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants Takeda Pharmaceuticals America, Inc. names for other drugs.

Recalls

• May 13, 2019 · Class II · Mallinckrodt Pharmaceuticals
  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.
  Lots: Lot #: 3229691-61, Exp 01/2022
• May 13, 2019 · Class II · Mallinckrodt Pharmaceuticals
  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.
  Lots: Lot #: 3200626-61, Exp 02/2022
• Nov 6, 2018 · Class III · Takeda Development Center Americas, Inc.
  Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
  Lots: Lot # 3098628-61, exp. date 02/28/2021

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Product details

Generic drug

Lubiprostone: every company that makes it

Form

capsule, gelatin coated, oral

Strength

8 ug

Approval

NDA NDA021908

On the market since

Jan 31, 2006

Package NDCs

64764-080-40 64764-080-60

Official label

DailyMed (National Library of Medicine), updated Jan 18, 2024

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