FDA-Drug2019-05-29Class II
Amitiza (lubiprostone) capsules, 24 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-240-60
MALLINCKRODT PHARMACEUTICALS
Hazard
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.
Sold states
US Nationwide
Affected count
80,640 bottles
Manufactured in
1425 Us Highway 206, N/A, Bedminster, NJ, United States
Products
Amitiza (lubiprostone) capsules, 24 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-240-60
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1295-2019Don't want to check this manually?
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