| Recall Number | D-0803-2026 |
|---|---|
| Recalling Firm | Mallinckrodt Hospital Products Inc. |
| Classification | Class II |
| Voluntary / Mandated | Voluntary: Firm initiated |
| Distribution Pattern | USA Nationwide |
| Status | Ongoing |
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
Presence of particulate matter: glass and stopper piece
Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027