Class II

Drug Recall: Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1

Mallinckrodt Hospital Products Inc. · February 6, 2024

Reason for Recall

cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.

Distribution

USA nationwide

States Affected

NATIONWIDE

Quantity Affected

8 vials involved in recall (16,479 vials distributed)

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0340-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.