Home / Recalls / MALLINCKRODT PHARMACEUTICALS / D-1295-2019

D-1295-2019 Class II Terminated

Recalled by MALLINCKRODT PHARMACEUTICALS — Bedminster, NJ

Recall Details

Product Type: Drugs
Report Date: May 29, 2019
Initiation Date: May 13, 2019
Termination Date: July 17, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 80,640 bottles

Product Description

Amitiza (lubiprostone) capsules, 24 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-240-60

Reason for Recall

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.

Distribution Pattern

US Nationwide

Code Information

Lot #: 3200626-61, Exp 02/2022