Drug 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
D-0340-2024
Product summary
- Event
- Event 93945
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8 vials involved in recall (16,479 vials distributed)
- Official record key
drug-enforcement:D-0340-2024
Official wording
Reason: cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Code information: Lot #: 1564-103, Exp 9/30/2024
Distribution pattern: USA nationwide
Derived failure modes
-
Manufacturing or process control
cGMP deviations