NDC 54868-6153

Amitiza 8 ug capsule, gelatin coated

On the label: Physicians Total Care, Inc.. It's repackaged: Physicians Total Care, Inc. rebottles it from Takeda Pharmaceuticals America, Inc.'s NDC 64764-080.

Where the pills inside were 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.

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.

Generic drug: Lubiprostone: every company that makes it
Form: capsule, gelatin coated
Strength: 8 ug
Approval: NDA NDA021908
On the market since: Aug 19, 2010
Package NDCs: 54868-6153-0 64764-080-60
Official label: DailyMed (National Library of Medicine), updated May 18, 2010

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