Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC 63004-8710-2
Recall Number: D-0803-2026
Firm: Mallinckrodt Hospital Products Inc.
Classification: Class II
Status: Ongoing
Report Date: 20260902
Initiation Date: 20260806
Termination Date:
Reason for Recall
Presence of particulate matter: glass and stopper piece
Product Description
Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC 63004-8710-2