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Medicine / D-0803-2026

U.S. Food and Drug AdministrationD-0803-2026

Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 &…

Class II Distributed nationwide or U.S.-wide Status: Ongoing

What was recalled

Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC 63004-8710-2

Recalling firm

Mallinckrodt Hospital Products Inc.

Reason for recall

Presence of particulate matter: glass and stopper piece

Where it went

USA Nationwide

Shown as U.S. Food and Drug Administration published it (shortened where marked …). Recall Shelf does not change recall facts and is not affiliated with the agency.