FDAFebruary 6, 2024drug
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 recall recorded by the U.S. Food & Drug Administration.
The hazard
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
What to do
FDA enforcement status: Ongoing
Brands named
mallinckrodt hospital productsmallinckrodtmallinckrodt hospital
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDADairy House Ingredient Systems Vanilla Dairy Powder, 50 lb box2026-05-18
- FDADairy House Ingredient Systems Strawberry Dairy Powder 05#5072-50, 50 lb bags2026-05-18
- FDAHydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T32026-04-24
- FDAPremier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08.2026-04-14
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