FDA Drug Class II — Moderate

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

Hazard

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

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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
Brand
Mallinckrodt Hospital Products Inc.
UPC
Lot #: 1564-103, Exp 9/30/2024

Units Affected

8 vials involved in recall (16,479 vials distributed)

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