Mallinckrodt Hospital Products Inc.: Drug Recall

Recall #D-0340-2024 · 02/06/2024

Class II: Risk

Recall Details

Recall Number: D-0340-2024
Classification: Class II
Product Type: Drug
Recalling Firm: Mallinckrodt Hospital Products Inc.
Status: Ongoing
Date Initiated: 02/06/2024
Location: Bridgewater, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 8 vials involved in recall (16,479 vials distributed)

Reason for Recall

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

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

Distribution Pattern

USA nationwide

Other Recalls by Mallinckrodt Hospital Products Inc.

Class II: Risk 02/06/2024

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

View all recalls by Mallinckrodt Hospital Products Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.