Class IIOngoing

Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL) recall

FDA recall D-0340-2024 · initiated Feb 6, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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

Details

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
Recalling company: Mallinckrodt Hospital Products Inc.
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: USA nationwide
Initiated: Feb 6, 2024
FDA report date: Feb 28, 2024

This recall is linked to a product we cover: Acthar Gel →

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0340-2024 ↗

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