Mallinckrodt Hospital Products Inc.: Acthar Gel (repository Corticotropin Injection)

Recalling firm
Mallinckrodt Hospital Products Inc.
Product
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
Reason
Presence of particulate matter: glass and stopper piece
Classification
Class II
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-08-06
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
USA Nationwide

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/9dee64ea-a12e-4228-a53b-d159307de2de