Mallinckrodt Hospital Products Inc. Provisional
FDA Flags (3)
Class II RecallSep 2026
Mallinckrodt Hospital Products Inc.
Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridg
Classification: Class II
Class II RecallFeb 2024
Mallinckrodt Hospital Products Inc.
Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only, Distributed by: Mallinckrodt Hospital Pro
Classification: Class II
Class II RecallFeb 2024
Mallinckrodt Hospital Products Inc.
Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, Mf
Classification: Class II