Acthar Gel 400 USP units/ recalled over manufacturing violations
- Recall date
- February 6, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Mallinckrodt Hospital Products Inc. recalls Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, M…
- Recall number
- D-0340-2024
- FDA classification
- Class II
- Brand / firm
- Mallinckrodt Hospital Products Inc.
- Sold / distributed
- USA nationwide
Why it was recalled
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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