MALLINCKRODT PHARMACEUTICALS recalls Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64…

Recall date

May 13, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1294-2019

FDA classification

Class II

Brand / firm

MALLINCKRODT PHARMACEUTICALS

Sold / distributed

US Nationwide

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-080-60