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FDARecalled Sep 2, 2026 · #D-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 & NDC 63004-8710-2

Hazard

Class II — temporary health risk

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Description

Presence of particulate matter: glass and stopper piece Classification: Class II Distribution: USA Nationwide

Product details

Product
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
Type
Drugs
Manufacturer
Mallinckrodt Hospital Products Inc.
Model numbers
NDC
UPCs
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