Home / Recalls / Mallinckrodt Hospital Products Inc. / D-0340-2024

D-0340-2024 Class II Ongoing

Recalled by Mallinckrodt Hospital Products Inc. — Bridgewater, NJ

Recall Details

Product Type: Drugs
Report Date: February 28, 2024
Initiation Date: February 6, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 8 vials involved in recall (16,479 vials distributed)

Product Description

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

Reason for Recall

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

Distribution Pattern

USA nationwide

Code Information

Lot #: 1564-103, Exp 9/30/2024