MALLINCKRODT PHARMACEUTICALS recalls Amitiza (lubiprostone) capsules, 24 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64
Recalled May 29, 2019 · FDA recall D-1295-2019 · 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. · FDA Class II
Units
80,640 bottles
Sold at
US Nationwide
Description
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.
Product
Amitiza (lubiprostone) capsules, 24 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-240-60
Manufacturer(s)
MALLINCKRODT PHARMACEUTICALS
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →