Mallinckrodt Hospital Products Inc. recalls Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, Mf
Recalled February 28, 2024 · FDA recall D-0340-2024 · Mallinckrodt Hospital Products
Hazard
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified. · FDA Class II
Units
8 vials involved in recall (16,479 vials distributed)
Sold at
USA nationwide
Description
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Product
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
Manufacturer(s)
Mallinckrodt Hospital Products Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →