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Mallinckrodt Hospital Products Inc. FDA Recalls
3 recalls on file across drugs, 0 of them Class I and 3 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, BridgClass IIAug 6, 2026Presence of particulate matter: glass and stopper piece |
| Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only, Distributed by: Mallinckrodt Hospital ProClass IIFeb 6, 2024cGMP deviations: Temperature excursion due to shipping delay |
| Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, MfClass IIFeb 6, 2024cGMP deviations: Temperature excursion due to shipping delay |