Recalls / Class II
Class IID-1294-2019
Product
Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-080-60
- Brand name
- Amitiza
- Generic name
- Lubiprostone
- Active ingredient
- Lubiprostone
- Route
- Oral
- NDCs
- 64764-080, 64764-240
- FDA application
- NDA021908
- Affected lot / code info
- Lot #: 3229691-61, Exp 01/2022
Why it was recalled
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.
Recalling firm
- Firm
- MALLINCKRODT PHARMACEUTICALS
- Manufacturer
- Takeda Pharmaceuticals America, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1425 Us Highway 206, N/A, Bedminster, New Jersey 07921-2653
Distribution
- Quantity
- 89,808 bottles
- Distribution pattern
- US Nationwide
Timeline
- Recall initiated
- 2019-05-13
- FDA classified
- 2019-05-23
- Posted by FDA
- 2019-05-29
- Terminated
- 2023-07-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1294-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.