Drug product
Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-080-60
D-1294-2019
Product summary
- Event
- Event 82830
- Status
- Terminated
- Classification
- Class II
- Quantity
- 89,808 bottles
- Official record key
drug-enforcement:D-1294-2019
Official wording
Reason: 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.
Code information: Lot #: 3229691-61, Exp 01/2022
Distribution pattern: US Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Label mix-up