Drug recall D-0340-2024
Product
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
Reason for recall
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Lots and codes
Lot #: 1564-103, Exp 9/30/2024
Recall details
- Recalling firm
- Mallinckrodt Hospital Products Inc., Bridgewater, NJ
- Quantity
- 8 vials involved in recall (16,479 vials distributed)
- Distribution
- USA nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 6, 2024
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