A Class II recall of Acthar Gel (repository corticotropin injection) was initiated on February 6, 2024. The recall, identified as D-0340-2024, was announced by Mallinckrodt Hospital Products Inc.
The affected product is Acthar Gel, 400 USP units per 5mL (80 USP units/mL), supplied in a 5mL multiple-dose vial, NDC 63004-8710-1. It was manufactured for Mallinckrodt ARD LLC of Bridgewater, NJ.
According to the recall notice, the action stems from cGMP deviations. Specifically, a temperature excursion occurred due to a shipping delay between the manufacturer and the distributor. The affected distributor has been notified of the issue.
The recall status is listed as ongoing. It is classified as Class II, a designation assigned by the FDA. No additional details about the scope of distribution or further outcomes were provided in the available record.
This recall pertains to a specific manufacturing and distribution issue involving temperature control during shipping. The event data does not include information about adverse events or product performance related to this recall. Readers seeking more background on corticotropin can consult the compound overview for additional context.</body_markdown>
<parameter name="sources">["https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts"]