FDA-Drug2024-02-28Class II
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.
Hazard
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Sold states
USA nationwide
Affected count
8 vials involved in recall (16,479 vials distributed)
Manufactured in
440 Us Highway 22, Ste 302, Bridgewater, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0340-2024Don't want to check this manually?
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