Drug recall D-0803-2026
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
Reason for recall
Presence of particulate matter: glass and stopper piece
Lots and codes
Lot#: NDC 63004-8710-1 - 1564-107, exp 1/31/2027 NDC 63004-8710-2 - 1564-107H, exp 1/31/2027
Recall details
- Recalling firm
- Mallinckrodt Hospital Products Inc., Bridgewater, NJ
- Quantity
- 12367 vials
- Distribution
- USA Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 6, 2026
Related products
- Acthar – drug information
- NDC 63004-8711 Acthar · Corticotropin 80 [USP'U]/mL · Mallinckrodt ARD LLC
- NDC 63004-8712 Acthar · Corticotropin 40 [USP'U]/.5mL · Mallinckrodt ARD LLC
- NDC 63004-8710 Acthar · Corticotropin 80 [USP'U]/mL · Mallinckrodt ARD LLC